Cleared Traditional

K063295 - ACON UTI URINARY TRACT INFECTION TEST STRIPS

K063295 is an FDA 510(k) clearance for ACON UTI URINARY TRACT INFECTION TEST S..., manufactured by ACON Laboratories, Inc.. The device is a Class 1 Chemistry device with product code LJX cleared through the Traditional 510(k) pathway after a 345-day FDA review.

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

FDA 510(k) Submission Details - K063295

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 88d · This submission: 345d
Pathway characteristics
Predicate-based equivalence.

LJX Device Classification - Class 1, General Controls

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.

Regulatory Peers - LJX Test, Urine Leukocyte

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