# K981920: AMM

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 22, 1998 after 51 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 K870787 (1987). 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)
- K870787: Abbott Spectrum Ammonia Reagent, Abbott Laboratories (1987) 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/K981920
Methodology: https://510kreport.com/methodology