Cleared Traditional

XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT (K020226) - FDA 510(k) Clearance

Also marketed or referenced as:
CATALOG NUMBERS S1383.01, S1383.02 & S1383.03

Class I Microbiology device.

K020226 · Hellen Professional Services · Microbiology device
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Aug 2002
Decision
212d
Days
Class 1
Risk

K020226 is an FDA 510(k) clearance for the XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT. Classified as Kit, Screening, Trichomonas (product code JWZ), Class I - General Controls.

Submitted by Hellen Professional Services (Northridge, US). The FDA issued a Cleared decision on August 22, 2002 after a review of 212 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K020226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date August 22, 2002
Days to Decision 212 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 102d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JWZ Kit, Screening, Trichomonas
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.