Cleared Traditional

K131444 - UA-CELLULAR COMPLETE

K131444 is the FDA 510(k) clearance for UA-CELLULAR COMPLETE by Streck. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K131444 · Streck · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2014
Decision
254d
Days
Class 1
Risk

K131444 is an FDA 510(k) clearance for the UA-CELLULAR COMPLETE. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on January 29, 2014 after a review of 254 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 Streck devices

Submission Details

510(k) Number K131444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date January 29, 2014
Days to Decision 254 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
166d slower than avg
Panel avg: 88d · This submission: 254d
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 36
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K131444.
AUTION CHECK PLUS
K142262 · Quantimetrix Corp. · Apr 2015
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
K103387 · ACON Laboratories, Inc. · Feb 2011
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · Cliniqa Corporation · Jan 2009
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