# K012337: Bayer Advia Ims System; C-Reactive Protein System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 6, 2001 after 135 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 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
The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device intended to measure C-Reactive Protein in human serum. Measurements of CRP are used in the evaluation and treatment on injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.

Source page: https://510kreport.com/device/K012337
Methodology: https://510kreport.com/methodology