# K964009: Immage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob) Reagent / Beckman Drug Claibrator 3 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 11, 1997 after 127 days
- Product code: DNO (Hemagglutination Inhibition, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- 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 K904226 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904226: 'Tdxflx Analyzer, Abbott Laboratories (1990) Summary page 1.

## Indications for use
The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Iimmunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay. Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.

Source page: https://510kreport.com/device/K964009
Methodology: https://510kreport.com/methodology