# K171498: MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Meso Scale Diagnostics, LLC
- Decided: Jan 12, 2018 after 234 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
Longest line of descent: 3 generations back to K895880 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073277: Roche-Creactive Protein (Latex), Roche Diagnostics Corp. (2008) Summary page 4.

## Indications for use
The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO® SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K171498
Methodology: https://510kreport.com/methodology