510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k090588

B. Purpose for Submission:

This is a new 510(k) to support the integration of a Power Processor Sample
Processing System to the UniCel DxI 600/800 Access Immunoassay System
(k023764) using cleared Vitamin B12, Ferritin, Folate and TSH Access
Immunoassays to show acceptable performance.

C. Measurand:
Vitamin B12, Ferritin, Folate and TSH

D. Type of Test:
Quantitative Chemiluminescent Immunoassay

E. Applicant:
Beckman Coulter, Inc.

F. Proprietary and Established Names:

Power Processor Sample Processing System with Generic Connection Module,
Model: 4210

G. Regulatory Information:
1. Regulation section:
21CFR Sec.-862.1810 - Vitamin B12 test system.
21CFR Sec.-866.5340 - Ferritin immunological test system.
21CFR Sec.-862.1295 - Folic acid test system.
21CFR Sec.-862.1690 - Thyroid stimulating hormone test system.
21CFR Sec.- 862.2160 - Discrete photometric chemistry analyzer for clinical use.

2. Classification:
II, II, II, II, I respectively

3. Product code:
CDD - Radioassay, Vitamin B12
DBF - Ferritin, Antigen, Antiserum, Control
CGN - Acid, Folic, Radioimmunoassay
JLW - Radioimmunoassay, Thyroid-Stimulating Hormone
JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

4. Panel:
Chemistry (75) Immunology (91)
H. Intended Use:
1. Intended use(s):
See indication(s) for use below.

2. Indication(s) for use:

The basic Power Processor is an automated sample handling system which
processes sample tubes from the pre-centrifugation, pre-sorting step to
presentation of centrifuged and decapped samples into Generic or Personality
Racks for specific instruments. The Power Processor can be configured with
optional software and hardware to allow processing of sample tubes on Generic
Connection Instruments. The Power Processor performs all pre-analytical sample
tube preparation, and then sorts the sample tubes directly to Generic Connection
Modules where the samples are pipetted by the Generic Connection instrument
for testing. After the samples are pipetted, the tubes can route to other instruments
for additional testing or to Outlet Racks.

The UniCel DxI 800 Access Immunoassay System with laboratory automation
connection is a microcomputer-controlled, random and continuous access
analyzer that includes an external computer. This computer stores the system user
interface (UI) software and allows the operator to interface with and direct the
instrument software. The UniCel DxI 800 System uses enzyme immunoassays
(utilizing paramagnetic particle solid phase and chemiluminescent detection) for
determination of various analytes, such as Vitamin B12, Ferritin, Folate and
hTSH along with other various enzyme immunoassays assays that may be
adaptable to the analyzer depending on the reagent used to induce the enzyme
immunoassay reaction. The UniCel DxI 800 System is an in vitro diagnostic
device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for

the quantitative determination of ferritin levels in human serum and plasma
(heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in
the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent

immunoassay for the quantitative determination of folic acid levels in human
serum, plasma (heparin) and red blood cells using the Access Immunoassay
Systems. Folic acid measurements are used in the diagnosis and treatment of
megaloblastic anemia.

The Access HYPER sensitive hTSH assay is a paramagnetic particle,

chemiluminescent assay for the quantitative determination of human thyroid-
stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access
Immunoassay Systems. Measurements of thyroid stimulating hormone produced
by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
 The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent
assay for the quantitative determination of vitamin B12 in human serum and
plasma (heparin) using Access Immunoassay Systems. Measurements obtained by
this device are used in the diagnosis and treatment of anemias of gastrointestinal
malabsorption.

3. Special conditions for use statement(s):

Prescription use

4. Special instrument requirements:

UniCel DxI 800 Access Immunoassay System

I. Device Description:
The Power Processor is a scalable laboratory automation system (LAS) designed to
streamline pre-analytical processes in the clinical laboratory. A basic Power
Processor System is comprised of a Line Control Computer, Preplink™ Computer,
Inlet Module, Hematology Module, Centrifugation Module, Decapper Module, and
Outlet Module. In the basic configuration, patient sample tubes are loaded onto the
Power Processor system to be sorted to a Hematology Module, or to be centrifuged,
decapped, and sorted to Personality Racks for further processing on other
instruments. Additional modules may be added for aliquot capability, sample
capping, and refrigerated storage.

The Power Processor is an open architecture system that can connect to a variety of
clinical analyzers. Connection modules are extensions of the Power Processor track
system that link with an analyzer’s existing LAS interface. Connection modules
support one of two types of sample transfer methods: onboard or outboard sampling.
Onboard sampling physically transfers the sample tube/rack from the automation
track to the analyzer’s sample load and identification area. With outboard sampling,
the connection unit performs the sample bar code read function, presents the sample
ID to the connected analyzer, and then signals for direct sampling of the open tube by
the connected instrument at an aspiration point on the automation track. The Power
Processor Generic Connection Module is specifically designed to support the
outboard sampling method based on point-in space pipetting technology aligned with
the CSLI guidelines. This method is used to establish connection with Beckman
Coulter’s UniCel DxI 800 Immunoassay System. Power Processor software version
3.5 establishes a dynamic or “smart” connection with the UniCel DxI 800 System to
enable sample routing based on reagent and calibration status.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Predicate Device 510(k) Number

Siemens (Dade Behring) StreamLAB® Analytical k043546
WorkCell/Sample Transfer Module
 Beckman Coulter UniCel® DxI 800 Access® k023764
Immunoassay System
Beckman Coulter Access® Ferritin Assay k926221
Beckman Coulter Access® Folate Assay k060774
Beckman Coulter Access® HYPERsensitive hTSH k042281
Assay
Beckman Coulter Access® Vitamin B12 Assay k955436

2. Predicate 510(k) number(s):

See Predicate Device table above.

3. Comparison with predicate:

Aspect/ Device Predicate

Characteristic
The basic Power Processor is an automated
sample handling system which processes
sample tubes from the pre-centrifugation,
pre-sorting step to presentation of
centrifuged and decapped samples into
Generic or Personality Racks for specific
instruments. The system is designed to free
laboratory personnel from biohazard Same: Automated sample
exposure and routine sample preparation. handling, routing, and
Intended Use The Power Processor can be configured management system designed
with optional software and hardware to to increase productivity and
allow processing of sample tubes . The improve operator safety.
Power Processor performs all preanalytical
sample tube preparation, then sorts the
sample tubes directly to Generic Connection
Modules where the samples are pipetted for
testing. After the samples are pipetted, the
tubes can route to other instruments for
additional testing or to Outlet Racks.
Open LAS architecture enables multiple
System Design analyzer connections. Scalable, modular Same
configuration.
Sample Outboard sampling capability using the
Transfer analyzer’s existing LAS interface and Same, using STM device.
Method Generic Connection Module.
Outboard analyzer connections are based on
Fundamental
"Point-in-space" pipetting technology Same
Technology
aligned with CSLI guidelines.
Operating Operating Software, Computer Console
Same
Environment with Single User Interface
System The core Power Processor System is Control unit, operator
 Aspect/ Device Predicate
Characteristic
Modules comprised of a line controller computer, a interface, sample input/output
system console with PrepLink™ software, module, decapping module,
inlet module, hematology module, track transport module. The
centrifugation module, decapper module, centrifugation module is
track transport system, and output module. optional, and the STM device
The Generic Connection module is an is an optional module to
optional module to enable analyzer enable analyzer connectivity.
connectivity.
Identification of patient tubes and sample
Positive sample identification
Sample programming using bar codes. Does not use
via a barcode reader and RFID
Identification Radio Frequency Identification Device
chip.
(RFID) sample identification.
The ability to interface with a LIS device to
receive patient identification and test
Sample
requests via a communications protocol to Same
Handling
provide sample tracking via bar code
labeling.

K. Standard/Guidance Document Referenced (if applicable):

• IEC 61326-2-6 IEC: Electrical equipment for measurement, control and

laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro
diagnostic (IVD) medical equipment. 12/15/2005
• AUTO5-A CSLI: Laboratory Automation: Electromechanical Interfaces;
Approved Standard. 3/1/2001

L. Test Principle:
Paramagnetic particle solid phase and chemiluminescent detection with an automated
sample handling system

M. Performance Characteristics (if/when applicable):

Assay performance characteristics were established in Beckman Coulter Access®
Ferritin Assay k926221, Beckman Coulter Access® Folate Assay k060774,
Beckman Coulter Access® HYPERsensitive hTSH Assay k042281, Beckman
Coulter Access® Vitamin B12 Assay k955436.

1. Analytical performance:
a. Precision/Reproducibility:
Provided in above referenced assay 510(k)’s

b. Linearity/assay reportable range:

Provided in above referenced assay 510(k)’s

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Provided in above referenced assay 510(k)’s
 d. Detection limit:
Provided in above referenced assay 510(k)’s

e. Analytical specificity:
Provided in above referenced assay 510(k)’s

f. Assay cut-off:
Provided in above referenced assay 510(k)’s

2. Comparison studies:
a. Method comparison with predicate device:
In order to establish equivalence to manually introduced samples to the
analyzer verses automated sample introduction and identification to the
analyzer a method comparison was performed using the above referenced
assays. The method comparison study employed paired sample testing and
Deming regression analysis to assess the data. The assay test menu was
selected by the evaluator and specimen selection was based on the site test
requests. In the study, two blood samples were drawn from each patient. One
sample tube was processed through the laboratory protocol using the Power
Processor System with Generic Connection Module interface to the DxI 800
analyzer, and the other tube was processed on the AutoMate system and
manually loaded on the analyzer.

The Deming regression analysis demonstrates comparable performance across

the range of sample concentrations tested for each representative assay.

DxI assay Sample N Slope Intercept r Comparative

(manual Range Method
sample
processing)
Vitamin B12 94 -671 101 0.912 23.88 0.983 DxI 800
Ferritin 3 - 993 101 1.042 -4.37 0.995 Analyzer w/
Folate 11 - 42 85 0.944 1.19 0.982 automated
sample
Hypersensitive 0.46 – 104 1.005 0.01 0.994
processing
TSH 12.09
(Power
Processor w/
Generic
Connection
Module)

The sponsor’s evaluator determined the test results showed no clinically

significant difference in assay performance between the two sample
processing methods. This data demonstrates substantial equivalence between
DxI 800 System with Power Processor connection and the predicate
stand-alone analyzer.
 b. Matrix comparison:
Provided in above referenced assay 510(k)’s

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable

b. Clinical specificity:
Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Provided in above referenced assay 510(k)’s

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:

Provided in above referenced assay 510(k)’s

N. Instrument Name:

Power Processor Sample Processing System with Generic Connection Module

O. System Descriptions:

1. Modes of Operation:

The Power Processor system can consist of the following interfaces: Instrument
Manager, PrepLink, and Line Control Computer. The LIS sends sample
programming to the PrepLink through the optional Instrument Manager in some
software setups. Sample programming information is used to determine where to
sort sample tubes. The Instrument Manager consolidates multiple sample
programming requests for each sample tube, allowing the Power Processor system
to sort sample tubes to the appropriate racks.

The PrepLink receives sample programming information which is used to

determine the routing information when queried by the Line Control Computer.
PrepLink sorts sample tubes to racks based on sample programming and rack
configurations specified by the operator during setup.

The Line Control software communicates with the PrepLink software to keep
track of sample tubes on the Power Processor system. The Line Control software
sends and receives information from the PrepLink software and the Power
Processor track. This information is contained in the Systems Error Log and the
Operations Error Log (both can be used to evaluate and correct processing
problems). The Line Control Computer Main screen displays a graphical
representation of the automation line.
 The Power Processor can be configured with optional hardware to automatically
load centrifuged and decapped sample tubes onto Beckman Coulter’s 800 DxI
System. The Connection Modules operate identically and are designed to support
an onboard sampling mechanism, where the sample tubes are transferred directly
to the connected analyzer sample load area and read by the system barcode reader.

The Power Processor can be configured with optional software and hardware to
allow processing of sample tubes on Connection Instrument. The Power Processor
performs all pre-analytical sample tube preparation, and then sorts the sample
tubes directly to Connection Module where the samples are pipetted for testing.
After the samples are pipetted, the tubes can route to other instruments for
additional testing or to Outlet Racks. Routing decisions are made by the PrepLink,
and are based on the sample programming of each sample tube, the availability of
the Connection instrument, and configuration parameters set by the operator.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development

processes for this line of product types:

Yes ___X_____ or No ________

The applicant provided software documentation that supports the device was
designed and developed under good software LifeCycle processes.

3. Specimen Identification:

Bar code

4. Specimen Sampling and Handling:

On the DxI 800 connection, the Connection Module reads the sample bar code
read prior to releasing the sample from the aspiration point, resulting in the
following sequence from the DxI perspective:

• Read sample data

• Verify sample data matches software queue
• Aspirate sample from tube
• Read sample data again
• Does sample data read before and after aspiration match? If Yes, keep sample
and perform analysis; if No, discard sample and do not perform analysis
• Release Sample from Aspiration point

5. Calibration:

Provided in k023764
 6. Quality Control:

Provided in k023764

P. Other Supportive Instrument Performance Characteristics Data Not Covered In

The “Performance Characteristics” Section above:

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:
The submitted information in this premarket notification is complete and supports a
substantial equivalence decision.