Cleared Traditional

K081908 - CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

K081908 is an FDA 510(k) clearance for CLINIQA LIQUID QC URINALYSIS CONTROLS, manufactured by Cliniqa Corporation. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K081908 · Cliniqa Corporation · Chemistry device
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Jan 2009
Decision
197d
Days
Class 1
Risk

K081908 is an FDA 510(k) clearance for the CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 197 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 Cliniqa Corporation devices

FDA 510(k) Submission Details - K081908

510(k) Number K081908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date January 16, 2009
Days to Decision 197 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 88d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

JJW Device Classification - Class 1, General Controls

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 44
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K081908.
UA-CELLULAR COMPLETE
K131444 · Streck · Jan 2014
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K110846 · Randox Laboratories Limited · Sep 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
K103387 · ACON Laboratories, Inc. · Feb 2011
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242 · Bayer Healthcare, LLC · Oct 2005
RANDOX URINE CONTROLS
K043266 · Randox Laboratories, Ltd. · Feb 2005
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · Bio-Rad Laboratories, Inc. · Nov 2004