# K040579: Choletech LDX High-Sensitivity C-Reactive Protein (HS-CRP)

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Jun 18, 2004 after 106 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 2 (0 Class I)
- 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) Dade Behring N High Sensitivity CRP assay on the BN-100: named in the summary without a submission number

## Recalls of this device
- Mar 6, 2013 · Class II · Z-1178-2013: The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCR
- Aug 9, 2006 · Not classified · Z-2457-2008: Test results are high, outside of control material upper limit specification. Results could be as high as 15%.

## Indications for use
Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.

Source page: https://510kreport.com/device/K040579
Methodology: https://510kreport.com/methodology