# K252619: Qscheck Uisacr

- Pathway: 510(k) (Traditional)
- Applicant: Qstag, Inc.
- Decided: Feb 20, 2026 after 185 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K890577 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182384: ACR  LAB Urine Analysis Test System, Healthy.Io, Ltd. (2019) Summary page 5.

## Indications for use
QSCHECK UISACR is intended for the in vitro semi-quantitative measurement of the following parameters: microalbumin and creatinine in urine specimens and for Albumin/Creatinine ratio (ACR) calculated using those values. The results may be used in conjunction with clinical evaluation as an aid in the assessment for kidney function. The system is intended for prescription use only, in clinical laboratory settings.

Source page: https://510kreport.com/device/K252619
Methodology: https://510kreport.com/methodology