Cleared Traditional

K242209 - UASure II Blood Uric Acid Monitoring System (FDA 510(k) Clearance)

Class I Chemistry device.

K242209 · Apex BioTechnology Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
249d
Days
Class 1
Risk

K242209 is an FDA 510(k) clearance for the UASure II Blood Uric Acid Monitoring System. Classified as Uric Acid Test System For At Home Prescription Use (product code PTC), Class I - General Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 4, 2025 after a review of 249 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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.

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Submission Details

510(k) Number K242209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2024
Decision Date April 04, 2025
Days to Decision 249 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
161d slower than avg
Panel avg: 88d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PTC Uric Acid Test System For At Home Prescription Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
Definition For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.