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GKZ Product Classification

The document provides information on the classification of a differential cell counter by the FDA. It notes that the device is classified as a class 2 medical device and is intended for use in hematology. The device is not exempt from Good Manufacturing Practice regulations and is subject to 510(k) premarket review by the Office of In Vitro Diagnostics and Division of Immunology and Hematology Devices. The document lists several consensus standards that apply to the device and notes that it is not eligible for third party review.

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48 views2 pages

GKZ Product Classification

The document provides information on the classification of a differential cell counter by the FDA. It notes that the device is classified as a class 2 medical device and is intended for use in hematology. The device is not exempt from Good Manufacturing Practice regulations and is subject to 510(k) premarket review by the Office of In Vitro Diagnostics and Division of Immunology and Hematology Devices. The document lists several consensus standards that apply to the device and notes that it is not eligible for third party review.

Uploaded by

sellappan marappan
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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4/14/23, 10:00 AM Product Classification

FDA Home3 Medical Devices4 Databases5


Product Classification
New Search Back to Search Results

Device Counter, Differential Cell


Regulation Medical Specialty Hematology
Review Panel Hematology
Product Code GKZ
Premarket Review Office of In Vitro Diagnostics6 (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report7
GMP Exempt? No
Summary Malfunction
Ineligible
Reporting
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
7-145 CLSI H42-A2 (Replaces H42-A)
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved
Guideline - Second Edition. 8
7-150 CLSI H43-A2
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline -
Second Edition9
7-163 CLSI H56-A (Replaces H56-P)
Body Fluid Analysis for Cellular Composition; Approved Guideline.10
7-165 CLSI H20-A2 (Replaces H20-A)
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental
Methods; Approved Standard - Second Edition11
7-210 CLSI H26-A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed
Standard - Second Edition12
7-277 CLSI GP41 7th Edition
Collection of Diagnostic Venous Blood Specimens13
Third Party Review Not Third Party Eligible

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3. https://www.fda.gov/
4. https://www.fda.gov/Medical-Devices
5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/medical-device-databases
6. https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-
organization#OHT7

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7. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=2432
8. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=26069
9. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29734
10. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=21789
11. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29738
12. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=31790
13. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=37753

Page Last Updated: 04/10/2023


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4. https://www.fda.gov/Medical-Devices
5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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6. https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-
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7. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=2432
8. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=26069
9. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29734
10. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=21789
11. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29738
12. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=31790
13. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=37753

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