# K011958: CRP-Latex (II) Seiken High Sensitivity Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken'S
- Decided: Dec 4, 2001 after 165 days
- Product code: DCN (System, Test, C-Reactive Protein)
- 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 its predicate without a number.
- (no number) N High Sensitivity CRP Assay: named in the summary without a submission number

## Indications for use
The CRP-Latex (I) SEIKEN High Sensitivity Assay kit is a quantitative assay for use with an Automated Chemical Analyzer for the determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury, and inflammatory disorders.

Source page: https://510kreport.com/device/K011958
Methodology: https://510kreport.com/methodology