# K994296: Dimension C3 Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 1, 2000 after 71 days
- Product code: CZW (Complement C3, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- 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 K780913 (1978). 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)
- K780913: Additional Reagents Kits for Imm. System, Beckman Instruments, Inc. (1978) Summary page 1.
- K922273: Array (R) 360, Beckman Instruments, Inc. (1992) Summary page 1.

## Indications for use
The C3 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C3 (C3) in serum as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.

Source page: https://510kreport.com/device/K994296
Methodology: https://510kreport.com/methodology