Cleared Traditional

AIMSTICK URINE REAGENT STRIPS (K051727) - FDA 510(k) Clearance

Class I Chemistry device.

K051727 · Germaine Laboratories, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
120d
Days
Class 1
Risk

K051727 is an FDA 510(k) clearance for the AIMSTICK URINE REAGENT STRIPS. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Germaine Laboratories, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 26, 2005 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - 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. Standard predicate reliance. 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 Germaine Laboratories, Inc. devices

Submission Details

510(k) Number K051727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2005
Decision Date October 26, 2005
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEN Dye-indicator, Ph (urinary, Non-quantitative)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
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.