Counter, Cell, Automated (particle Counter)

Device Code: 2311

Product Code(s): GKL

Device Classification Information

• Device Type ID: 2311
• Device Name: Counter, Cell, Automated (particle Counter)
• Regulation Description: Automated Cell Counter.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.5200 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GKL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-71 CLSI H15-A3 (Replaces H15-A2)
  Reference And Selected Procedures For The Quantitative Determination Of Hemoglobin In Blood; Approved Standard - Third Edition
• 7-163 CLSI H56-A (Replaces H56-P)
  Body Fluid Analysis For Cellular Composition; Approved Guideline.
• 7-210 CLSI H26-A2
  Validation, Verification, And Quality Assurance Of Automated Hematology Analyzers; Proposed Standard - Second Edition

Total Product Life Cycle

• Device Type ID: 2311
• Device: Counter, Cell, Automated (particle Counter)
• Product Code: GKL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Cell Counter.
• CFR Regulation Number: 864.5200 [🔎]

Premarket Reviews
Manufacturer	Decision
ADVANCED INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Handling Problem	2
Thermal Decomposition Of Device	1
Mechanical Problem	1
Smoking	1
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Instruments, LLC	II	Dec-19-2018
2	BD Biosciences, Systems & Reagents	II	Jan-20-2015
3	Becton, Dickinson And Company, BD Biosciences	III	Apr-14-2016

TPLC Last Update: 2019-04-02 20:09:25