# K971469: Coulter Act Tron Cell Control

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Jun 30, 1997 after 69 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: 2 generations back to K823355 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964988: Coulter AC.T Series Analyzer, Coulter Corp. (1997) Summary page 1.

## Indications for use
COULTER® A°-T TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on COULTER® AT Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.

Source page: https://510kreport.com/device/K971469
Methodology: https://510kreport.com/methodology