# K964781: Immage Immunochemistry System Prealbumin (Pab) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 9, 1997 after 163 days
- Product code: DDS (Prealbumin, Fitc, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 PAB Prealbumin Reagent: named in the summary without a submission number

## Indications for use
The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrater 3, is intended for use in the guantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.

Source page: https://510kreport.com/device/K964781
Methodology: https://510kreport.com/methodology