Cleared Traditional

K051526 - URITEK-720+ URINE ANALYZER

K051526 is an FDA 510(k) clearance for URITEK-720+ URINE ANALYZER, manufactured by Teco Diagnostics. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K051526 · Teco Diagnostics · Chemistry device
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Aug 2005
Decision
69d
Days
Class 1
Risk

K051526 is an FDA 510(k) clearance for the URITEK-720+ URINE ANALYZER. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K051526

510(k) Number K051526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2005
Decision Date August 16, 2005
Days to Decision 69 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

KQO Device Classification - Class 1, General Controls

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 23
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K051526.
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 151 URINE ANALYZER, MODEL TC-151
K042421 · Teco Diagnostics · May 2005
BAYER CLINITEK STATUS ANALYZER
K031947 · Bayer Healthcare, LLC · Dec 2003
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998