# K060464: Coulter 5C Cell Control

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 28, 2006 after 34 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912133 (1991). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912133: PX Coulter (R) Cell Control, Coulter Electronics, Inc. (1991) Summary page 1.

## Most influential descendants
- K081822: Coulter 6C Cell Control, Models 628027 & A59925 (2009), 3 descendants of its own
- K181599: Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (2019), 2 descendants of its own
- K193124: Unicel DxH 800 Coulter Cellular Analysis System (2020), 1 descendant of its own
- K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (2024), 0 descendants of its own
- K082162: Coulter Body Fluid Control (2009), 0 descendants of its own

## Indications for use
5C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your Product Manuals or On-Line Help System.) The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.

Source page: https://510kreport.com/device/K060464
Methodology: https://510kreport.com/methodology