# K090137: Stak-Chex Plus Retics

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Mar 18, 2009 after 56 days
- Product code: GLQ (Mixture, Control, White-Cell And Red-Cell Indices)
- 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 K905524 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992887: Stak-Chex Plus Retics, Streck Laboratories, Inc. (1999) Summary page 1.

## Indications for use
STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated procedures that measure blood cell parameters.

Source page: https://510kreport.com/device/K090137
Methodology: https://510kreport.com/methodology
