# K061742: Uryxxon Relax Urine Analyzer

- Pathway: 510(k) (Special)
- Applicant: Macherey-Nagel GmbH & Co. KG
- Decided: Sep 6, 2006 after 78 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- 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.

## Indications for use
The URYXXON® Relax is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes metabolic abnormalities, liver diseases, biliary and hepatic obstructions of the kidneys and urinary tract. The test provided on MACHEREY-NAGEL Reagent strips for the determination of specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis.

Source page: https://510kreport.com/device/K061742
Methodology: https://510kreport.com/methodology