# K192118: CRP Vario

- Pathway: 510(k) (Special)
- Applicant: SENTINEL CH. SpA
- Decided: Nov 8, 2019 after 94 days
- Product code: DCK (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: 4 generations back to K860894 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050836: CRP Diagnostic Assay, Sentinel Ch. Srl (2005) Summary page 5.

## Indications for use
The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR): CRP Calibrators are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum or plasma samples.

Source page: https://510kreport.com/device/K192118
Methodology: https://510kreport.com/methodology