Cleared Traditional

K141874 - URISCAN OPTIMA

K141874 is the FDA 510(k) clearance for URISCAN OPTIMA by Yd Diagnostics Corp.. It is a Class 1 Chemistry device (product code KQO) cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K141874 · Yd Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
May 2015
Decision
321d
Days
Class 1
Risk

K141874 is an FDA 510(k) clearance for the URISCAN OPTIMA. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Yd Diagnostics Corp. (Gangnam-Gu, KR). The FDA issued a Cleared decision on May 28, 2015 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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. Elevated predicate reliance profile. 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 Yd Diagnostics Corp. devices

Submission Details

510(k) Number K141874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2014
Decision Date May 28, 2015
Days to Decision 321 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
233d slower than avg
Panel avg: 88d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
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 - KQO Automated Urinalysis System

All 22
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K141874.
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
K142543 · ACON Laboratories, Inc. · May 2015
CLINITEK NOVUS
K140717 · Siemens Healthcare Diagnostics · Nov 2014
COBAS U411 TEST SYSTEM
K093555 · Roche Diagnostics · Apr 2010
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · ACON Laboratories, Inc. · Jul 2007
URITEK-720+ URINE ANALYZER
K051526 · Teco Diagnostics · Aug 2005
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421 · Teco Diagnostics · May 2005