August 10, 2023

Instrumentation Laboratory Company

Gabriella Erdosy
Director of Regulatory Affairs
180 Hartwell Road
Bedford, Massachusetts 01730

Re: K223608
Trade/Device Name: GEM Premier 7000 with iQM3
Regulation Number: 21 CFR 862.1120
Regulation Name: Blood Gases (pCO2, pO2) and Blood pH Test System
Regulatory Class: Class II
Product Code: CHL, JGS, CEM, CGZ, JFP, CGA, KHP, MQM, GKF, GKR, GHS, GLY
Dated: July 10, 2023
Received: July 11, 2023

Dear Gabriella Erdosy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
K223608 - Gabriella Erdosy Page 2

801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR
803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D.
Acting Deputy Director
Division of Chemistry
and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K223608

Device Name

GEM Premier 7000 with iQM3

Indications for Use (Describe)

The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly
analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central
laboratory.The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized
calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*)
parameters from arterial, venous, or capillary lithium heparinized whole blood. These parameters, along with derived
parameters, aid in the diagnosis of a patient’s acid/base status, electrolyte and metabolite balance and oxygen delivery
capacity.

*sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

• pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of
life-threatening acid- base disturbances.
• Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or
vary with electrolytes:
– Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes
insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic
secretion, or other diseases involving electrolyte imbalance.
– Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and
treatment
of disease conditions characterized by low or high blood potassium levels.
– Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid
disease, a variety of bone diseases, chronic renal disease, and tetany.
– Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic
disorders, such as cystic fibrosis and diabetic acidosis.
• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are
used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in
the number of red cells).
• Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate
metabolism
disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and
pancreatic islet cell carcinoma.
• Lactate (Lac) measurement is used:
– to evaluate the acid-base status of patients suspected of having lactic acidosis;
– to monitor tissue hypoxia and strenuous physical exertion;
– in the diagnosis of hyperlactatemia.
• Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and
hyperbilirubinemia in neonates.
• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry
oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional
hemoglobin species.
– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content
of whole blood for the detection of anemia.
– COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human
FORM FDA 3881 (6/20) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF
blood as an aid in the diagnosis of carbon monoxide poisoning.
– MetHb: Methemoglobin measurements are used to determine different conditions of
methemoglobinemia.
– HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with
oxyhemoglobin to measure oxygen status.
– O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with
deoxyhemoglobin to measure oxygen status.
– sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin
and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 2 of 2

 K223608: GEM Premier 7000 with IQM3

510(k) Summary

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements
of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

Instrumentation Laboratory (IL) Co.

Submitter’s Information 180 Hartwell Road
Bedford, MA 01730, USA

Gabriella Erdosy
Director of Regulatory Affairs
Contact Person Phone: 781-861-4571
Fax: 781-861-4207
Email: [email protected]

Preparation Date August 10, 2023

Device Trade Name GEM Premier 7000 with iQM3

Predicate Device GEM Premier 5000 K203790

K223608: 510(k) Summary Page 1 of 12

 Regulatory Information

GEM Premier 7000 with iQM3

Regulation Product
Analyte Regulatory Description Class Panel
Section Code
Blood Gases (pCO2, pO2) and Blood pH
pH, pCO2, pO2, 862.1120 II CHL
system

Sodium 862.1665 Sodium test system II JGS

Potassium 862.1600 Potassium test system II CEM

Chloride 862.1170 Chloride test system II CGZ

75
Ionized Calcium 862.1145 Calcium test system II JFP

Glucose 862.1345 Glucose test system II CGA

Lactate 862.1450 Lactic acid test system I* KHP

Bilirubin (total and unbound) I

Total Bilirubin 862.1113 MQM
in the neonate test system (Reserved)

Hematocrit 864.5600 Automated hematocrit instrument II GKF

864.7425 Carboxyhemoglobin assay II GHS

81
CO-Oximetry 864.5620 Automated hemoglobin system II GKR

864.7500 Whole blood hemoglobin assays II GLY

* Meets limitations of exemptions per 21 CFR 862.9(c)(9)

Special Conditions for Use Statement

• For prescription use only.
• For clinical laboratory and point-of-care use.

K223608: 510(k) Summary Page 2 of 12

 Device Description

The GEM Premier 7000 with iQM3

The GEM Premier 7000 with iQM3 system provides health care professionals with quantitative measurements of
lithium heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-
Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*) from arterial, venous or capillary samples at the point of health care
delivery in a clinical setting and in a central laboratory.
*sO2 = Ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

Key Components Description

It employs a unique touch-sensitive color screen and a simple set of menus
Instrument and buttons for user interaction. The analyzer guides operators through
the sampling process with simple, clear messages and prompts.

All required components for sample analysis are contained in the GEM PAK,
including sensors, optical cell for CO-Oximetry and total bilirubin, sampler,
pump tubing, distribution valve, waste container and Process Control
Solutions. The GEM PAK is an entirely closed analytical system. The operator
cannot introduce changes to the analytical process before or during the
GEM PAK’s use-life on board the instrument.
The GEM PAK has flexible menus and test volume options to assist facilities
in maximizing efficiency. The EEPROM on the GEM PAK includes all solution
values and controls the analyte menu and number of tests.
The setup of the instrument consists of inserting the GEM PAK into the
instrument. The instrument will perform an automated GEM PAK start-up
during which the following is performed: warm-up (15 minutes), sensor
conditioning (10 minutes), Process Control Solution (PCS) performance (15
PAK (Cartridge) minutes), all of which take about 40 minutes.
After GEM PAK start-up, Auto PAK Validation (APV) process is automatically
completed: two completely independent solutions traceable to NIST
standards, CLSI procedures or internal standards, containing two levels of
concentration for each analyte (PC Solution D and E), are run by the analyzer
to validate the integrity of the PC Solutions and the overall performance of
the analytical system.
Note: GEM PAKs that include tBili analyte will require the successful
performance of CVP 5 tBili.
Includes all necessary components for hemolysis detection, such as an
acoustofluidic flow cell, an LED light source and an optical detector, for
appropriate flagging of potassium measurements in whole blood samples
without additional sample volume or sample processing steps.

iQM3 is used as the quality control and assessment system for the GEM
Premier 7000 system. iQM3 is an active quality process control program
designed to provide continuous monitoring of the analytical process
Intelligent Quality Management before, during and after sample measurement with real-time, automatic
error detection, automatic correction of the system and automatic
(iQM3) documentation of all corrective actions, replacing the use of traditional
external QC.
iQM3 introduces hemolysis detection in whole blood samples, enhancing
quality assessment in the pre-analytical phase of testing.

K223608: 510(k) Summary Page 3 of 12

 Indications for Use / Intended Use
The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly
analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a
central laboratory.
The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized
calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*)
parameters from arterial, venous, or capillary lithium heparinized whole blood. These parameters, along with
derived parameters, aid in the diagnosis of a patient’s acid/base status, electrolyte and metabolite balance and
oxygen delivery capacity.
*sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.
 pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening
acid- base disturbances.
 Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with
electrolytes:
– Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes
insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic secretion, or
other diseases involving electrolyte imbalance.
– Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment
of disease conditions characterized by low or high blood potassium levels.
– Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a
variety of bone diseases, chronic renal disease, and tetany.
– Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic
disorders, such as cystic fibrosis and diabetic acidosis.
 Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used
to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number
of red cells).
 Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic
islet cell carcinoma.
 Lactate (Lac) measurement is used:
– to evaluate the acid-base status of patients suspected of having lactic acidosis;
– to monitor tissue hypoxia and strenuous physical exertion;
– in the diagnosis of hyperlactatemia.
 Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia
in neonates.
 CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by
measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin
species.
– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content
of whole blood for the detection of anemia.
– COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of
human blood as an aid in the diagnosis of carbon monoxide poisoning.
– MetHb: Methemoglobin measurements are used to determine different conditions of
methemoglobinemia.
– HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to
measure oxygen status.
– O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to
measure oxygen status.
– sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and
oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

K223608: 510(k) Summary Page 4 of 12

 Comparison to Predicate
The GEM Premier 7000 with iQM3 system is substantially equivalent in function and intended use to the following
predicate device:
• Predicate Device: GEM Premier 5000
Item Predicate Device New Device
Trade Names GEM Premier 5000 K203790 GEM Premier 7000 with iQM3
Manufacturers Instrumentation Laboratory Co. Instrumentation Laboratory Co.
The GEM Premier 5000 is a portable critical Same
care system for use by health care
professionals to rapidly analyze heparinized
whole blood samples at the point of health
care delivery in a clinical setting and in a central
laboratory.
The instrument provides quantitative
measurements of pH, pCO2, pO2, sodium,
potassium, chloride, ionized calcium, glucose,
lactate, hematocrit, total bilirubin, and CO-
Oximetry (tHb, O2Hb, COHb, MetHb, HHb,
sO2*) parameters from arterial, venous, or
capillary heparinized whole blood. These
parameters, along with derived parameters,
aid in the diagnosis of a patient’s acid/base
status, electrolyte and metabolite balance and
oxygen delivery capacity.
*sO2 = ratio between the concentration of
Indications for
oxyhemoglobin and oxyhemoglobin plus
Use
deoxyhemoglobin.
 pH, pCO2, and pO2 measurements in
whole blood are used in the diagnosis and
treatment of life-threatening acid- base
disturbances.
 Electrolytes in the human body have
multiple roles. Nearly all metabolic
processes depend on or vary with
electrolytes:
– Sodium (Na+) measurements are
used in the diagnosis and treatment
of aldosteronism, diabetes insipidus,
adrenal hypertension, Addison’s
disease, dehydration, inappropriate
antidiuretic secretion, or other
diseases involving electrolyte
imbalance.
– Potassium (K+) measurements are
used to monitor electrolyte balance
in the diagnosis and treatment of
disease conditions characterized by
low or high blood potassium levels.

K223608: 510(k) Summary Page 5 of 12

Indications for – Ionized calcium (Ca++)
Use measurements are used in the
(Continued) diagnosis and treatment of
parathyroid disease, a variety of
bone diseases, chronic renal
disease, and tetany.
– Chloride (Cl-) measurements are
used in the diagnosis and treatment
of electrolyte and metabolic
disorders, such as cystic fibrosis and
diabetic acidosis.
 Hematocrit (Hct) measurements in whole
blood of the packed red cell volume of a
blood sample are used to distinguish
normal from abnormal states, such as
anemia and erythrocytosis (an increase in
the number of red cells).
 Glucose (Glu) measurement is used in the
diagnosis, monitoring and treatment of
carbohydrate metabolism disturbances
including diabetes mellitus, neonatal
hypoglycemia, idiopathic hypoglycemia,
and pancreatic islet cell carcinoma.
 Lactate (Lac) measurement is used:
– to evaluate the acid-base status of
patients suspected of having lactic
acidosis;
– to monitor tissue hypoxia and
strenuous physical exertion;
– in the diagnosis of hyperlactatemia.
 Total Bilirubin (tBili) measurement is used
to aid in assessing the risk of kernicterus
and hyperbilirubinemia in neonates.
 CO-Oximetry (tHb, COHb, MetHb, O2Hb,
HHb, and sO2) evaluates the ability of the
blood to carry oxygen by measuring total
hemoglobin and determining the
percentage of functional and
dysfunctional hemoglobin species.
– Total Hemoglobin (tHb): Total
hemoglobin measurements are used
to measure the hemoglobin content
of whole blood for the detection of
anemia.
– COHb: Carboxyhemoglobin
measurements are used to determine
the carboxyhemoglobin content of
human blood as an aid in the
diagnosis of carbon monoxide
poisoning.
– MetHb: Methemoglobin
measurements are used to determine
different conditions of
methemoglobinemia.

K223608: 510(k) Summary Page 6 of 12

– HHb: Deoxyhemoglobin, as a fraction
of total hemoglobin, is used in
combination with oxyhemoglobin to
measure oxygen status.
– O2Hb: Oxyhemoglobin, as a fraction of
total hemoglobin, is used in
combination with deoxyhemoglobin to
measure oxygen status.
– sO2: Oxygen saturation, more
specifically the ratio between the
concentration of oxyhemoglobin and
oxyhemoglobin plus
deoxyhemoglobin, is used to measure
oxygen status.

K223608: 510(k) Summary Page 7 of 12

 Comparison to Predicate (Cont.)
NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000.
Item Predicate Device New Device
Trade Names GEM Premier 5000 K203790 GEM Premier 7000 with iQM3
Similarities
Intended User Central Laboratory and Point-of-Care Same
Potentiometry: pH and pCO2
Blood Gas Measurement Same
Amperometry: pO2
Electrolyte Measurement Potentiometry: Na+, K+, Cl-, Ca++ Same
Metabolite Measurement Amperometry: Glucose and Lactate Same
Spectrophotometry: tHb, O2Hb, COHb,
Hemoglobin Measurement Same
MetHb, HHb, sO2
Total Bilirubin Spectrophotometry Same
Hematocrit Measurement Conductivity Same
Sample Introduction Aspiration Same
Normal Mode 150 µL
Sampling Modes
and Micro Mode 65 µL Same
Sample Volumes tBili/CO-Ox Mode 100 µL

PAK Shelf-Life Stability Up to 180 days Same

PAK Storage Temperature 15-25°C Same
System Operating Temperature 12-32°C Same
Operating System Software Linux-based Same
Calibration 2-point calibration Same

K223608 510 (k) Summary Page 8 of 13

 Comparison to Predicate (Cont.)
NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000.
Item Predicate Device New Device
Trade Names GEM Premier 5000 K203790 GEM Premier 7000 with iQM3
Similarities (Continued)
Heparinized whole blood
Sample Type Same
(venous, arterial or capillary)
pH 7.00 to 7.92 Same
pCO2 6 to 125 mmHg Same
pO2 6 to 690 mmHg Same
Na+ 100 to 180 mmol/L Same
+
K 1.0 to 19.0 mmol/L Same
Ca++ 0.11 to 4.25 mmol/L Same
Cl- 40 to 158 mmol/L Same
Glucose 4 to 685 mg/dL Same
Reportable Range Lactate 0.3 to 17.0 mmol/L Same
Hematocrit 15 to 72% Same
tBili 2.0 to 40.0 mg/dL Same
tHb 3.0 to 23.0 g/dL Same
O2Hb 0.7 to 100.0% Same
COHb 0.3 to 75.0% Same
MetHb 0.7 to 30.0% Same
HHb 1.0 to 100.0% Same
sO2 0.7 to 100.0% Same

K223608 510 (k) Summary Page 9 of 13

 Comparison to Predicate (Cont.)
NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000
Item Predicate Device New Device
Trade Names GEM Premier 5000 K203790 GEM Premier 7000 with iQM3
Differences
GEM Premier 5000 Instrument: GEM Premier 7000 with iQM3
Instrument:
• Height: 18.6 inches • Height: 18.9 inches
Instrument Dimensions • Width: 12.9 inches
• Width: 13.0 inches
• Depth: 16.4 inches • Depth: Same
• Weight: 45.4 pounds • Weight: 45.3 pounds

GEM Premier 5000 PAK (Cartridge): GEM Premier 7000 PAK with iQM3
(Cartridge):
• Height: 6.75 inches • Height: 6.6 inches
Cartridge (PAK) Dimensions
• Width: 10 inches • Width: 10.2 inches
• Depth: 8 inches • Depth: 7.6 inches
• Weight: 8.1 pounds • Weight: Same
Addition of the new iQM quality check
The fluidic pathway directly connects
Fluidic Pathway module between Sensor Card and CO-
Sensor Card and CO-Ox module
Ox module
Additional time (11s) for the new iQM
Sample Fluidic Process Micro Mode (65 µL) quality check before analyte
measurements
PAK (Reagent) Bags Process Control Solution Bag (PCS) B Addition of Heparin
Cartridge fluidic components interface Modification to existing analyzer
Cartridge-Analyzer Interface with hardware components on the connection to support the iQM quality
analyzer check module
An analyzer capable of supporting the
An analyzer capable of supporting the
Instrument GEM Premier 7000 with iQM3
GEM Premier 5000 Cartridge (PAK)
Cartridge (PAK)
PAK Compatibility GEM Premier 5000 only GEM Premier 7000 with iQM3 only

K223608 510 (k) Summary Page 10 of 13

 Comparison to Predicate (Cont.)
NOTE: The following table compares iQM2 on the GEM Premier 5000 to iQM3 on the GEM Premier 7000.
Item Predicate Device New Device
Trade Names iQM2 (Intelligent Quality Management 2) iQM3 (Intelligent Quality Management 3)
Instrument GEM Premier 5000 GEM Premier 7000 with iQM3
510(k) No. K203790 K223608
Active quality process control program using Same
a combination of internal Auto PAK
Validation (APV) and one level of external
Calibration Valuation Product (CVP 5), five
internal Process Control Solutions (PCSs)
Quality Control
Pattern Recognition (PR) software and
Principle
IntraSpect sample integrity quality checks,
all of which are designed to provide
immediate error detection and automatic
remedial action, replacing the use of
traditional external quality controls.
Multi-level checks for detecting cartridge Same except addition of Hemolysis
errors. detection.
• System checks • Same, except addition of
Hemolysis detection
Error functionality
Detection • Sensor/CO-Oximetry checks • Same except the addition of
Scheme Hemolysis Module Checks
• IntraSpect checks • Same
• Pattern Recognition (PR checks) • Same
• Process Control Solution (PCS) Stability • Same
• Hemolysis detection
Automatic error handling: Same
• Performing special rinse cycle after
detecting micro-clots and verifying the
cartridge function after clot removal.
• Permanently disabling failed sensor if
its functionality could not be
Error Mitigation recovered.
• Rejecting cartridge for process stability
failure.
• Alerting the user if interferences are
detected in a sample.
• Automatically documenting the failure
and action taken.
• IntraSpect
Automatic documentation: Same
• Process Control Solutions delta charts.
Documentation • Error reporting and corrective action
report.
• GEM CVP report.

K223608 510 (k) Summary Page 11 of 13

 Comparison to Predicate (Cont.)

NOTE: The following table compares internal Process Control (PC) Solutions in the GEM Premier 5000 PAK
(cartridge) to internal Process Control (PC) Solutions in the GEM Premier 7000 with iQM3 PAK (cartridge).
Category Predicate Device New Device

Trade Names Process Control (PC) Solutions Process Control (PC) Solutions

Instrument GEM Premier 5000 GEM Premier 7000 with iQM3

510(k) No. K203790 K223608

• PC Solution B is the primary Process • PC Solution B – Same, except the
Control Solution measured at a addition of Heparin
minimum of every half hour or after
every sample. Furthermore, Solution B
is monitored every 30 seconds while
residing in the sensor card between
measurements. Further, PC Solution B
is used as a reference blank for CO-
Oximetry.
• PC Solution A is measured at a minimum • PC Solution A – Same
of every 4 hours. All sensor slope values
are also measured and checked. Slope,
which is an indicator of sensor
sensitivity and drift, must be within
allowable limits. PC Solution A also
contains dyes that are used for checking
functionality of the optical cell and the
CO-Oximetry.
• PC Solution C is measured at a minimum • PC Solution C – Same
of once every 24 hours. PC Solution C is
primarily used for measuring low-level
PC Solutions oxygen; however, PC Solution C is also
used to provide an additional
measurement of pH, pCO2 and K+ sensor
functionality.
• PC Solution D is measured every 12 • PC Solution D – Same
hours. PC Solution D provides additional
measurement for all analytes including
CO-Oximetry. Reference values for
analytes in PC Solution D are assigned at
time of manufacturing. The D sensor
check starts after the successful
completion of Auto PAK Validation
(APV).
• PC Solution E is measured every 12 • PC Solution E – Same
hours. PC Solution E provides additional
measurement for all analytes including
CO-Oximetry. Reference values for
analytes in PC Solution E are assigned at
time of manufacturing. The E sensor
check starts after the successful
completion of Auto PAK Validation
(APV).

K223608 510 (k) Summary Page 12 of 13

 Performance Summary

Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium,
Hemolysis Verification), Shelf-life and Use-life studies were performed to establish that the modifications
introduced with the addition of the new iQM quality check (Hemolysis detection module) of the GEM Premier 7000
with IQM3 do not impact the performance data represented in the Operators Manual. These studies followed
recognized guidelines:

• CLSI EP05-A3

• CLSI EP07, 3rd Ed

• CLSI EP09c, 3rd Ed

• CLSI EP25-A

• CLSI EP37, 1st Ed

All verification activities were performed in accordance to established plans and protocols and design control
procedures. Testing verified that all acceptance criteria were met.

The technological and functional characteristics of the new GEM Premier 7000
with iQM3 as described above are substantially equivalent to that of the predicate
Conclusion device GEM Premier 5000. The analytical study results demonstrate that the GEM
Premier 7000 with iQM3 is safe and effective for its intended purpose and
equivalent in performance to the predicate device (K203790).

K223608 510 (k) Summary Page 13 of 13