Cleared Traditional

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

Device Classification

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 243
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K050352.
BBL(R) DMACA INDOLE REAGENT DROPPERS
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PATHODX PYR KIT
K902037 · Diagnostic Products Corp. · Jun 1990
LD PRESUMPTO QUAD
K871907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
ONPG SOLUTION
K863601 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
MS-2 BACTERIAL IDENTI. SYS
K830099 · Abbott Laboratories · Feb 1983
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1983