# K023269: Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 23, 2002 after 83 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 K991385 (1999). 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)
- K991385: Dade Behring N High Sensitivity CRP Assay, Dade Behring, Inc. (1999) Summary page 1.

## Indications for use
HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases. HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

Source page: https://510kreport.com/device/K023269
Methodology: https://510kreport.com/methodology