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.

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
Combination Product No
PCCP Authorized No
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 73
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K050801.
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280 · Iris International, Inc. · Jun 2006
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
K052525 · DFI Co., Ltd. · Mar 2006
URYXXON 200 URINE ANALYZER
K051034 · Macherey-Nagel GmbH & Co. KG · Nov 2005
CHEMVIEW-10
K042641 · Cenogenics Corp. · Jan 2005
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
K033851 · Hypoguard USA, Inc. · Mar 2004
COMBI-SCREEN, MODELS 10SL AND 11SL
K023885 · Analyticon Biotechnologies AG · Oct 2003
K050801 · URISCAN OPTIMA II URINE ANALYZER
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