Cleared Special

URISCAN OPTIMA II URINE ANALYZER (K050801) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050801 · Yd Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 80
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K050801.
AUTION MAX AX-4060 Urinalysis System
K193514 · Arkray, Inc. · Apr 2023
cobas u 601 urinalysis test system
K183432 · Roche Diagnostics · May 2019
DIP/U.S. Urine Analysis Test System
K173327 · Healthy.Io, Ltd. · Jul 2018
inui In-Home Urine Analysis Test System
K180356 · Scanadu, Inc. · May 2018
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024 · DFI Co., Ltd. · May 2018
DUS R-50S (Urine Chemistry system)
K171521 · DFI Co., Ltd. · Feb 2018