# K964010: Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage Immunochemistry System Apolipoprotein B Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 10, 1997 after 126 days
- Product code: MSJ (Apolipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K862019 (1986). 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)
- K862019: Ics Apolipoprotein a-1 Reagent Test Kit, Beckman Instruments, Inc. (1986) Summary page 1.
- K862386: Ics Apolipoprotein B Reagent Test Kit, Beckman Instruments, Inc. (1986) Summary page 1.

## Indications for use
The IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

Source page: https://510kreport.com/device/K964010
Methodology: https://510kreport.com/methodology