Cleared Special

K050801 - URISCAN OPTIMA II URINE ANALYZER

K050801 is an FDA 510(k) clearance for URISCAN OPTIMA II URINE ANALYZER, manufactured by Yd Diagnostics. The device is a Class 2 Chemistry device with product code JIL cleared through the Special 510(k) pathway after a 21-day FDA review.

K050801 · Yd Diagnostics · Chemistry device
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Apr 2005
Decision
21d
Days
Class 2
Risk

K050801 is an FDA 510(k) clearance for the URISCAN OPTIMA II URINE ANALYZER. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Yd Diagnostics (La Canada, US). The FDA issued a Cleared decision on April 20, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Yd Diagnostics devices

FDA 510(k) Submission Details - K050801

510(k) Number K050801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2005
Decision Date April 20, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 46
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K050801.
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · Teco Diagnostics · Feb 2011
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · Siemens Healthcare Diagnostics · Oct 2009
CLINITEK ADVANTUS, MODEL 1420
K063276 · Bayer Healthcare, LLC · Dec 2006
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
POCKETCHEM UA AUTION STICKS 10TA
K022386 · Arkray, Inc. · Sep 2002
URS-IG (GLUCOSE TEST)
K020175 · Teco Diagnostics · Mar 2002