# K080552: Cyto-Chex BCT

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Jul 31, 2008 after 154 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030596 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040107: Cyto-Chex BCT, Streck Laboratories, Inc. (2004) Summary page 1.

## Most influential descendants
- K162723: TransFix/EDTA Vacuum Blood Collection Tubes (2017), 0 descendants of its own

## Recalls of this device
- Feb 23, 2017 · Class II · Z-1684-2017: Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the mi

## Indications for use
Cyto-Chex ® BCTTM is intended for collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 14-day period following collection.

Source page: https://510kreport.com/device/K080552
Methodology: https://510kreport.com/methodology