# K961278: Coulter STKS Analyzer with CD4 & CD8 Lymphocyte Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Jul 22, 1996 after 110 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- 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 K885093 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922745: Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1, Coulter Immunology (1993) Summary page 1.
- K922744: Cyto-Stat/Coulter Clone CD 3(IGG1)-Fitc/T8-RD1, Coulter Immunology (1993) Summary page 1.
- K885093: Coulter STKS, Coulter Electronics, Inc. (1988) Summary page 1.
- K932030: Coulter STKS with Reticulocyte Analysis Capability, Coulter Corp. (1993) Summary page 1.

## Indications for use
COULTER STKS Analyzer with CD4 and CD8 Lymphocyte Analysis is a complete system consisting of reagents, sample processing accessories, instrument and software. The system is intended “For In Vitro Diagnostic Use” to identify and enumerate CD4+ and CD8+ T lymphocyte percentages and absolute counts in whole blood using either of two versions of a quantitative, automated hematology analyzer and leukocyte differential counter: COULTER® STKS Analyzer or COULTER® STKS Analyzer with Reticulocyte Analysis. The system is also intended to provide the CD4/CDS8 ratio, a complete blood count (CBC) and a white blood cell (WBC) differential. Reticulocyte percentage and absolute count are only available if using the COULTER® STKS Analyzer with Reticulocyte Analysis.

Source page: https://510kreport.com/device/K961278
Methodology: https://510kreport.com/methodology