Cleared Traditional

K070929 - ACON U120 URINE ANALYZER, MODEL U111-101

K070929 is an FDA 510(k) clearance for ACON U120 URINE ANALYZER, manufactured by ACON Laboratories, Inc.. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K070929 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
118d
Days
Class 1
Risk

K070929 is an FDA 510(k) clearance for the ACON U120 URINE ANALYZER, MODEL U111-101. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by ACON Laboratories, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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.

FDA 510(k) Submission Details - K070929

510(k) Number K070929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2007
Decision Date July 30, 2007
Days to Decision 118 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
29d slower than avg
Panel avg: 89d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

KQO Device Classification - Class 1, General Controls

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
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 - KQO Automated Urinalysis System

All 45
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K070929 · ACON U120 URINE ANALYZER, MODEL U111-101
Download PDF FDA Summary ACON Laboratories, In…