# K994294: Dimension TRNF Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 4, 2000 after 45 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- 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 TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Source page: https://510kreport.com/device/K994294
Methodology: https://510kreport.com/methodology