# K011855: Wampole HS-CRP Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Carter-Wallace, Inc.
- Decided: Jan 8, 2002 after 209 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 Wampole HS-CRP ELISA is an in vitro diagnostic enzyme-linked immunosorbent assay intended for the quantitative measurement of C-reactive protein (CRP) levels in human serum and plasma. CRP measurements aid in the evaluation of the extent of injury to body tissues.

Source page: https://510kreport.com/device/K011855
Methodology: https://510kreport.com/methodology