# K991597: Cobas Integra Amikacin Mab

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 22, 1999 after 73 days
- Product code: LGJ (Fluorescence Polarization Immunoassay, Amibacin)
- Device class: 2
- Regulation: 21 CFR 862.3035
- 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 K954992 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954992: Roche Cobas Integra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K032279: Online TDM Amika (2003), 0 descendants of its own

## Indications for use
The cassette COBAS INTEGRA Amikacin MAB contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.

Source page: https://510kreport.com/device/K991597
Methodology: https://510kreport.com/methodology