# K141874: Uriscan Optima

- Pathway: 510(k) (Traditional)
- Applicant: Yd Diagnostics Corp.
- Decided: May 28, 2015 after 321 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905396 (1991). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797, Siemens Healthcare Diagnostics (2009) Summary page 4.

## Most influential descendants
- K210069: Minuteful - kidney test (2022), 1 descendant of its own
- K222921: Minuteful-kidney test (2023), 0 descendants of its own

## Indications for use
The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results. The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters; Albumin Creatinine ACR (Albumin Creatinine Ratio) These measurements are useful in the evaluation of renal, urinary and metabolic disorders. URiSCAN Optima urine chemistry test system is intended for prescription use only, in clinical laboratory and in point-of-care setting.

Source page: https://510kreport.com/device/K141874
Methodology: https://510kreport.com/methodology