# K201256: Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Procise Diagnostics
- Decided: Nov 4, 2022 after 907 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: 1 generation back to K142993 (2016). 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)
- K142993: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument, Orion Diagnostica, OY (2016) Summary page 4.

## Indications for use
The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human scrum. The test is carried out by means of the ProciseDx Analyzer. Measurement of CRP aids in evaluation of injury to body tissues, infection, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point of care use.

Source page: https://510kreport.com/device/K201256
Methodology: https://510kreport.com/methodology