# K080016: NRBC-Chex for Advia

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Feb 5, 2008 after 33 days
- Product code: GJR (Control, Red-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 K000945 (2000). 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)
- K060083: NRBC-Chex for LH, Streck (2006) Summary page 1.

## Indications for use
nRBC-Chex for ADVIA® is an assayed whole blood control designed to evaluate the accuracy and precision of the Siemens Healthcare Diagnostics Inc. hematology analyzers in the measurement of the nucleated red blood cell parameter. Refer to product assay sheet.

Source page: https://510kreport.com/device/K080016
Methodology: https://510kreport.com/methodology