# K974110: Immage Immunochemistry System Antithrombin Iii (AT3) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Dec 24, 1997 after 54 days
- Product code: JBQ (Antithrombin Iii Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7060
- 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 K901977 (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)
- K901977: Beckman Antithrombin Iii Reagent Kit, Beckman Instruments, Inc. (1990) Summary page 1.

## Indications for use
The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin II by rate nephelometry. The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin II by rate nephelometry.

Source page: https://510kreport.com/device/K974110
Methodology: https://510kreport.com/methodology