# K221119: RCRP Flex reagent cartridge

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 17, 2023 after 333 days
- Product code: DCN (System, Test, C-Reactive Protein)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003419 (2001). 1 ancestor in all.
1 later device descends 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)
- K003419: RCRP Flex Reagent Cartridge, Dade Behring, Inc. (2001) Summary page 4.

## Most influential descendants
- K232624: CardioPhase® hsCRP (2023), 0 descendants of its own

## Recalls of this device
- Aug 17, 2026 · Class II · Z-3335-2026: The potential for falsely elevated results.
- Mar 11, 2025 · Class II · Z-1551-2025: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

## Indications for use
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Source page: https://510kreport.com/device/K221119
Methodology: https://510kreport.com/methodology