Cleared Traditional

K142262 - AUTION CHECK PLUS

K142262 is the FDA 510(k) clearance for AUTION CHECK PLUS by Quantimetrix Corp.. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K142262 · Quantimetrix Corp. · Chemistry device
Download Printable Device Report (PDF)
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Apr 2015
Decision
239d
Days
Class 1
Risk

K142262 is an FDA 510(k) clearance for the AUTION CHECK PLUS. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on April 10, 2015 after a review of 239 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Quantimetrix Corp. devices

Submission Details

510(k) Number K142262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2014
Decision Date April 10, 2015
Days to Decision 239 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
151d slower than avg
Panel avg: 88d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJW Urinalysis Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJW Urinalysis Controls (assayed And Unassayed)

All 27
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K142262.
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
K103387 · ACON Laboratories, Inc. · Feb 2011
RANDOX URINE CONTROLS
K043266 · Randox Laboratories, Ltd. · Feb 2005
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · Bio-Rad Laboratories, Inc. · Nov 2004
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · Medical Analysis Systems, Inc. · Jul 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
K031231 · Bio-Rad · Jun 2003
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
K023928 · Medical Analysis Systems, Inc. · Dec 2002