# K051114: Sentinel Ammonia Ultra Diagnostic Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: Nov 25, 2005 after 207 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913346 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974620: Ammonia-Incorporating Dynamic Stabilization Technology (DST), Trace America, Inc. (1998) Summary page 2.
- K913346: Quantimetrix Ammonia Controls, Quantimetrix Corp. (1991) Summary page 2.

## Recalls of this device
- Sep 22, 2015 · Class II · Z-0164-2016: Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

## Indications for use
The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.

Source page: https://510kreport.com/device/K051114
Methodology: https://510kreport.com/methodology