# K052719: Uritest 10 Urinalysis Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Arj Medical, Inc.
- Decided: Dec 5, 2006 after 432 days
- Product code: CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bayer Corporation MULTTSTIX 10 SG Reagent Strips: named in the summary without a submission number

## Most influential descendants
- K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers (2009), 1 descendant of its own
- K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own
- K091472: Uritest 50 and Uritest 500 Urine Analyzer (2010), 0 descendants of its own

## Indications for use
URITEST 10 Urinalysis Reagent Strips provide qualitative and semni-quantitative tests for glucose, bilimbin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria. ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Source page: https://510kreport.com/device/K052719
Methodology: https://510kreport.com/methodology