| K-number | K252619 |
| Device name | QSCHECK UISACR |
| Applicant | Qstag, Inc. |
| Product code | JFY |
| Device class | Class II |
| Decision date | Feb 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.1225 |
QSCHECK UISACR is a urine test system consisting of reagent strips and a smartphone app that measures microalbumin and creatinine levels in urine specimens to calculate the albumin-to-creatinine ratio (ACR) as an aid in assessing kidney function. The system uses smartphone cameras (iPhone 14 or Galaxy S23) to photograph and analyze color changes on the test strips, intended for prescription use only in clinical laboratory settings.
The subject device measures the same analytes (microalbumin and creatinine) with identical measurement ranges (microalbumin 1-15 mg/dL; creatinine 10-300 mg/dL) as the predicate device. Both use the same test principles: dye-binding for microalbumin and dye-metal complex reaction for creatinine. The key difference is the instrument platform: the subject device uses modern smartphones (Galaxy S23, iPhone 14 with Android v16 and iOS v26) versus the predicate's iPhone 7 with iOS v12.
CLSI EP05-A3 for precision/repeatability studies, CLSI EP07 for interference testing, CLSI EP37 for supplemental interference testing tables, and EN ISO 13485:2016 for stability testing protocols.
The QSCHECK UISACR demonstrates substantial equivalence to the predicate ACR LAB device based on identical intended use (semi-quantitative measurement of microalbumin and creatinine for ACR calculation in kidney function assessment), identical measurement ranges and test principles, and analytical performance studies showing 100% match rates for precision, linearity, and reproducibility across multiple operators and test sites. Clinical method comparison of 300 patient specimens achieved >85% exact match rate and >95% within-one-block match rate against the predicate device.
View the full FDA submission: accessdata.fda.gov