Cleared Traditional

K252619 - QSCHECK UISACR

K252619 is an FDA 510(k) clearance for QSCHECK UISACR, manufactured by Qstag, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K252619 · Qstag, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
185d
Days
Class 2
Risk

K252619 is an FDA 510(k) clearance for the QSCHECK UISACR. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Qstag, Inc. (Incheon, KR). The FDA issued a Cleared decision on February 20, 2026 after a review of 185 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Qstag, Inc. devices

FDA 510(k) Submission Details - K252619

510(k) Number K252619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2025
Decision Date February 20, 2026
Days to Decision 185 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 88d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFY Enzymatic Method, Creatinine

All 33
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K252619.
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · Siemens Healthcare Diagnostics, Inc. · Nov 2021
Yumizen C1200 Creatinine PAP
K193649 · HORIBA ABX SAS · May 2021
ACR LAB Urine Analysis Test System
K182384 · Healthy.Io, Ltd. · Jul 2019
GEM Premier ChemSTAT
K183555 · Instrumentation Laboratory CO · Feb 2019
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · Yd Diagnostics Corporation · Dec 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
K182063 · Ortho-Clinical Diagnostics, Inc. · Oct 2018