# K062924: Stratus CS Acute Care Cardiophase Hscrp Testpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 26, 2006 after 89 days
- Product code: NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991385 (1999). 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)
- K060369: Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak, Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Nov 11, 2015 · Class II · Z-0614-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

## Indications for use
The Stratus® CS Acute Care Tm CardioPhase®hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Source page: https://510kreport.com/device/K062924
Methodology: https://510kreport.com/methodology