Cleared Traditional

K051727 - AIMSTICK URINE REAGENT STRIPS

K051727 is an FDA 510(k) clearance for AIMSTICK URINE REAGENT STRIPS, manufactured by Germaine Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CEN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K051727 · Germaine Laboratories, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K051727

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.

CEN Device Classification - Class 1, General Controls

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.