# K212559: CardioPhase® hsCRP

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Dec 16, 2022 after 490 days
- Product code: NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control)
- 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: 2 generations back to K991385 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033908: N High Sensitivity CRP, Dade Behring, Inc. (2004) Summary page 5.

## Most influential descendants
- K233242: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (2024), 0 descendants of its own

## Indications for use
CardioPhase® hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C‑reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. 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/K212559
Methodology: https://510kreport.com/methodology