# K072658: Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Apr 1, 2008 after 194 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: 1 generation back to K992662 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992662: 8 Additional Assays for the Bayer Advia 1650 Chemistry System, Bayer Corp. (2000) Summary page 1.
- K022682: Randox C-Reactive Protein Calibrator, Randox Laboratories, Ltd. (2002) Summary page 2.

## Indications for use
The ADVIA CHEMISTRY C-Reactive Protein_2 assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin) on the ADVIA Chemistry systems. Such measurements are used in the evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Increases in CRP values are non-specific for many disease processes and should not be interpreted without a complete clinical evaluation. The ADVIA Chemistry C-Reactive Protein_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the C-Reactive Protein_2 (CRP_2) method.

Source page: https://510kreport.com/device/K072658
Methodology: https://510kreport.com/methodology