Cleared Traditional

K020226 - XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT

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

K020226 is an FDA 510(k) clearance for XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TES..., manufactured by Hellen Professional Services. The device is a Class 1 Microbiology device with product code JWZ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

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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FDA 510(k) Submission Details - K020226

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.

JWZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JWZ Kit, Screening, Trichomonas

Devices cleared under the same product code (JWZ) and FDA review panel - the closest regulatory comparables to K020226.
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864 · Genzyme Corp. · Apr 2004
MERIVIEW TM TRICHOMONAS
K894246 · Meridian Diagnostics, Inc. · Aug 1989
SUPER DUO
K892802 · Mercia Diagnostics , Ltd. · Jun 1989
MERIFLUOR(TM) -TRICHOMONAS
K892263 · Meridian Diagnostics, Inc. · May 1989
TRICHOMATE(R) SUPER
K875138 · Mercia Diagnostics , Ltd. · May 1988
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
K852665 · Syncor Intl. Corp. · Aug 1985