# K003419: RCRP Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 14, 2001 after 104 days
- Product code: DCN (System, Test, C-Reactive Protein)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K221119: RCRP Flex reagent cartridge (2023), 1 descendant of its own
- K232624: CardioPhase® hsCRP (2023), 0 descendants of its own

## Recalls of this device
- Apr 15, 2008 · Not classified · Z-1930-2009: falsely elevated results in EDTA plasma samples

Source page: https://510kreport.com/device/K003419
Methodology: https://510kreport.com/methodology