# K083724: Wiener Lab. Urine Strip 10 and 11

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratorios Saic
- Decided: Sep 2, 2009 after 261 days
- Product code: JIO (Blood, Occult, Colorimetric, In Urine)
- Device class: 2
- Regulation: 21 CFR 864.6550
- 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. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“k83724”).
- (no number) Bayer Multistix® 10SG: named in the summary without a submission number

## Indications for use
Urine strip test strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations. Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine. Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.

Source page: https://510kreport.com/device/K083724
Methodology: https://510kreport.com/methodology