# K962294: Immage Immunochemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Aug 21, 1996 after 68 days
- Product code: JQX (Nephelometer, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771603 (1977). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922273: Array (R) 360, Beckman Instruments, Inc. (1992) Summary page 1.
- K771603: Immochemistry System, Beckman Instruments, Inc. (1977) Summary page 1.
- K780913: Additional Reagents Kits for Imm. System, Beckman Instruments, Inc. (1978) Summary page 1.
- K926272: Beckman Transferrin Kit, Beckman Instruments, Inc. (1993) Summary page 1.
- K862019: Ics Apolipoprotein a-1 Reagent Test Kit, Beckman Instruments, Inc. (1986) Summary page 1.
- K810306: Rheumatoid Factor Reagent Test Kit, Beckman Instruments, Inc. (1981) Summary page 1.
- K924186: Lpia-Ferritin Assay, Seradyn, Inc. (1992) Summary page 1.
- K882233: TDX (R) Digoxin NXT, Abbott Laboratories (1988) Summary page 1.
- K932127: TDX/Tdxflx & Tdxflx Theophylline Monoclonal II, Abbott Laboratories (1993) Summary page 1.
- K942328: N Latex RF, Behring Diagnostics, Inc. (1994) Summary page 1.

## Recalls of this device
- Aug 24, 2010 · Not classified · Z-2045-2011: The recall was initiated because Beckman Coulter has confirmed an Immage Systems Wash Solution Lot 71744 was manufactured by a Beckman European facility and not intended to be used in the U.S. However
- May 21, 2010 · Not classified · Z-2195-2010: Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Som

## Indications for use
The IMMAGE Immunochemistry System is a fully automated, computer controiled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.

Source page: https://510kreport.com/device/K962294
Methodology: https://510kreport.com/methodology