# K013169: Immune Cell Function Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cylex, Inc.
- Decided: Apr 2, 2002 after 193 days
- Product code: NID (Assay, Proliferation, In Vitro, T Lymphocyte)
- 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: 3 generations back to K946055 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971205: Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 2.
- K974360: Multitest CD3/CD8/CD45/CD4, Becton Dickinson Immunocytometry Systems (1998) Summary page 2.

## Indications for use
The Cylex Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. The Cylex Immune Cell Function Assay detects cell-mediated immunity (CMI) by measuring the concentration of ATP from CD4 cells following stimulation. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population.

Source page: https://510kreport.com/device/K013169
Methodology: https://510kreport.com/methodology