# K083040: S-Test C-Reactive Protein (CRP)

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Jan 30, 2009 after 108 days
- Product code: DCN (System, Test, C-Reactive Protein)
- Device class: 2
- Regulation: 21 CFR 866.5270
- 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 K961274 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961274: Olympus AU600 Clinical Chemistry Analyzer, Olympus America, Inc. (1996) Summary page 1.
- (no number) Olympus AU640 Clinical Chemistry Analyzer: named in the summary without a submission number

## Indications for use
The S-Test C-Reactive Protein Reagent Cartridge is intended for the quantitative determination of C-reactive protein concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K083040
Methodology: https://510kreport.com/methodology