Cleared Traditional

K050352 - IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

K050352 is an FDA 510(k) clearance for IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT, manufactured by Ameritek Research, LLC. The device is a Class 1 Chemistry device with product code JTO cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K050352 · Ameritek Research, LLC · Chemistry device
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Sep 2005
Decision
202d
Days
Class 1
Risk

K050352 is an FDA 510(k) clearance for the IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Ameritek Research, LLC (Mill Creek, US). The FDA issued a Cleared decision on September 1, 2005 after a review of 202 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - 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 Ameritek Research, LLC devices

FDA 510(k) Submission Details - K050352

510(k) Number K050352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date September 01, 2005
Days to Decision 202 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 88d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K050352.
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