# K030873: Randox Ammonia

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 12, 2003 after 53 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 30, 2020 · Class II · Z-2965-2020: Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
- Jul 30, 2020 · Class II · Z-2966-2020: Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

## Indications for use
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with a-ketoglutarate and NADPH in the presence of glutamate dehydrogenase (GLDH) to yield glutamate and NADP*. The corresponding decrease in absorbance at 340nm is proportional to the concentration of ammonia in the plasma. Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome. This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K030873
Methodology: https://510kreport.com/methodology