# K173833: CRP Vario

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Sep 27, 2018 after 283 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum RU plasma. Cardiac CRP High Sensitive (cCRP) may be used for aid in identification and stratification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the cCRP may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndrome.

Source page: https://510kreport.com/device/K173833
Methodology: https://510kreport.com/methodology