# K954570: Ortho Immunocount Flow Cytometry System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: Apr 30, 1996 after 211 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 K895127 (1989). 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)
- K896873: Coulter JT3, Coulter Corp. (1990) Summary page 1.
- K895127: ARGOS, Abx, Inc. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K93292: Simultest reagents. Number could not be read Summary page 1.
- K874383: Mentor Plus (Condom), Arcon Corp. (1988). Our OCR of the scanned summary read K874383, FDA’s number for Mentor Plus (Condom) (Arcon Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Coulter JT2”. Kept off the family tree. Summary page 1.

## Indications for use
ORTHO ImmunoCount Flow Cytometry System is intended to be used for lymphocyte immunophenotyping. Results may be reported as either percent positive cells, or as absolute counts of lymphocytes and lymphocyte subsets.

Source page: https://510kreport.com/device/K954570
Methodology: https://510kreport.com/methodology