Cleared Traditional

K070929 - ACON U120 URINE ANALYZER

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

K070929 · ACON Laboratories, Inc. · Chemistry device
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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.

View all ACON Laboratories, Inc. devices

Submission Details

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
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 21
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K070929.
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
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K031947 · Bayer Healthcare, LLC · Dec 2003