# K974620: Ammonia-Incorporating Dynamic Stabilization Technology (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: Jan 2, 1998 after 22 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051114: Sentinel Ammonia Ultra Diagnostic Assay (2005), 0 descendants of its own

## Recalls of this device
- Jul 24, 2007 · Not classified · Z-0015-2008: Method is susceptible to positive interference from endogenous ALT in patient samples.

## Indications for use
Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems. Ammonia measurements are used in the diagnosis and tredtment of severe liver disorders such as cirrhosis, hepatitus, and Reye's syndrome. " CFR 862.1065

Source page: https://510kreport.com/device/K974620
Methodology: https://510kreport.com/methodology