Cleared Traditional

URITEST 10 URINALYSIS REAGENT STRIPS (K052719) - FDA 510(k) Clearance

Class I Chemistry device.

K052719 · Arj Medical, Inc. · Chemistry device
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Dec 2006
Decision
432d
Days
Class 1
Risk

K052719 is an FDA 510(k) clearance for the URITEST 10 URINALYSIS REAGENT STRIPS. Classified as Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (product code CDM), Class I - General Controls.

Submitted by Arj Medical, Inc. (Oldsmar, US). The FDA issued a Cleared decision on December 5, 2006 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1785 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Arj Medical, Inc. devices

Submission Details

510(k) Number K052719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date December 05, 2006
Days to Decision 432 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
344d slower than avg
Panel avg: 88d · This submission: 432d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1785
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.