# K981467: AMM

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 22, 1998 after 60 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- 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 K914750 (1991). 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)
- K914750: Roche Cobas (R) Ammonia and Ethanol Calibrator, Roche Diagnostic Systems, Inc. (1991) Summary page 1.

## Indications for use
The Ammonia assay is used for the quantitation of ammonia in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye’s syndrome.

Source page: https://510kreport.com/device/K981467
Methodology: https://510kreport.com/methodology