# K050801: Uriscan Optima II Urine Analyzer

- Pathway: 510(k) (Special)
- Applicant: Yd Diagnostics
- Decided: Apr 20, 2005 after 21 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 UriScan Optima II Urine Analyzer is an automated system for use with UriScan disposable reagent strips for routine urinalysis through the analysis of blood, bilirubin, urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.

Source page: https://510kreport.com/device/K050801
Methodology: https://510kreport.com/methodology