# K981084: Uriscreen

- Pathway: 510(k) (Traditional)
- Applicant: Diatech Diagnostics,Inc.
- Decided: Oct 7, 1998 after 196 days
- Product code: JXA (Kit, Screening, Urine)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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. The FDA summary names its predicate without a number.
- (no number) MULTISTIX- Reagent Strip for Urinalysis: named in the summary without a submission number
- (no number) Uri-Test - Nitrite in Urine Test: named in the summary without a submission number

## Indications for use
Uriscreen is a non-quantitative rapid screen, which detects catalase. Urinary catalase may be associated with White Blood Cells, bacteria and other cells, some of which may be indicators of urinary tract infection. Only Adults should use the test.

Source page: https://510kreport.com/device/K981084
Methodology: https://510kreport.com/methodology