# K993126: CD-Chex CD 34

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Nov 26, 1999 after 67 days
- Product code: GGL (Control, White-Cell)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920997 (1992). 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)
- K960894: CD-Chex + RBC, Streck Laboratories, Inc. (1996) Summary page 1.

## Indications for use
A clinical laboratory performing quantitative stem cell analysis needs a control specimen for verifying the measurement process. CD Chex CD 34 is such a specimen. It consists of stabilized placental blood containing a population of CD 34 positive stem cells. It is used as a procedural control for monitoring monoclonal antibody binding in flow cytometry methods. Users of Becton Dickinson ProCount Progenitor Cell Enumeration Kit or ISHAGE protocol can validate their CD 34 results by controlling the procedure with CD Chex CD 34.

Source page: https://510kreport.com/device/K993126
Methodology: https://510kreport.com/methodology