# K963427: Immage Immunochemistry System Transferrin (TRF) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Oct 7, 1996 after 38 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman Immunochemistry Systems TRF Transferrin Reagent: named in the summary without a submission number

## Most influential descendants
- K042477: Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein (2004), 4 descendants of its own
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), 3 descendants of its own
- K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (2006), 1 descendant of its own
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own
- K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii (2006), 0 descendants of its own

## Indications for use
The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry.

Source page: https://510kreport.com/device/K963427
Methodology: https://510kreport.com/methodology