# K964695: Immage Immunochemistry System Albumin (Alb) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Apr 29, 1997 after 158 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 ALB Albumin Reagent: named in the summary without a submission number

## Most influential descendants
- K142346: Urine/CSF Albumin, Urine/CSF Albumin Calibrator (2014), 0 descendants of its own

## Indications for use
The IMMAGE Immunochemistry System Albumin (ALB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and CSF samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.

Source page: https://510kreport.com/device/K964695
Methodology: https://510kreport.com/methodology