# K183517: Ammonia II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Feb 8, 2019 after 52 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 K003196 (2000). 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)
- K003196: Synchron Systems Ammonia Reagent, Beckman Coulter, Inc. (2000) Summary page 5.

## Indications for use
The Ammonia II assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems. 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/K183517
Methodology: https://510kreport.com/methodology