# K960894: CD-Chex + RBC

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: May 24, 1996 after 80 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: 1 generation back to K920997 (1992). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920997: CD-Chex, Streck Laboratories, Inc. (1992). Our OCR of the scanned summary read K920937, FDA’s number for Computerized Pupil (Trek Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CD-Chex”.

## Most influential descendants
- K051633: CD-Chex Plus BC (2005), 1 descendant of its own
- K083926: CD4 Count (2009), 0 descendants of its own
- K993126: CD-Chex CD 34 (1999), 0 descendants of its own

## Indications for use
CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems

Source page: https://510kreport.com/device/K960894
Methodology: https://510kreport.com/methodology