Cleared Traditional

ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295) - FDA 510(k) Clearance

Class I Chemistry device.

K063295 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
345d
Days
Class 1
Risk

K063295 is an FDA 510(k) clearance for the ACON UTI URINARY TRACT INFECTION TEST STRIPS. Classified as Test, Urine Leukocyte (product code LJX), Class I - General Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 12, 2007 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7675 - 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. Elevated predicate reliance profile. 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K063295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date October 12, 2007
Days to Decision 345 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 88d · This submission: 345d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJX Test, Urine Leukocyte
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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.