# K081213: BD Facscount CD4 Reagents with Model 339010

- Pathway: 510(k) (Traditional)
- Applicant: Bd Biosciences
- Decided: Aug 14, 2008 after 106 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933486 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071143: BD Tritest CD3/CD4/CD45, Model 340383, Bd Biosciences (2007) Summary page 1.
- K071141: BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402, Bd Biosciences (2007) Summary page 1.

## Recalls of this device
- Jun 15, 2015 · Class III · Z-2090-2015: Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and I
- Jan 29, 2009 · Not classified · Z-1007-2010: The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.

## Indications for use
BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

Source page: https://510kreport.com/device/K081213
Methodology: https://510kreport.com/methodology