# K051034: Uryxxon 200 Urine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Macherey-Nagel GmbH & Co. KG
- Decided: Nov 22, 2005 after 214 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
Longest line of descent: 1 generation back to K960546 (1996). 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)
- K960546: Clinitek 50 Urine Chemistry Analyzer, Bayer Corp. (1996) Summary page 1.
- (no number) URYSIS 1100 Urine Analyzer: named in the summary without a submission number

## Indications for use
The URYXXON® 200 is a portable reflectance photometer that instrumentally measures the reflectance off a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The product 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 and diseases 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/K051034
Methodology: https://510kreport.com/methodology