Cleared Traditional

K020595 - XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01

K020595 is an FDA 510(k) clearance for XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, manufactured by Xenotope Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JWZ cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K020595 · Xenotope Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
363d
Days
Class 1
Risk

K020595 is an FDA 510(k) clearance for the XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01. Classified as Kit, Screening, Trichomonas (product code JWZ), Class I - General Controls.

Submitted by Xenotope Diagnostics, Inc. (Northridge, US). The FDA issued a Cleared decision on February 20, 2003 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Xenotope Diagnostics, Inc. devices

FDA 510(k) Submission Details - K020595

510(k) Number K020595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2002
Decision Date February 20, 2003
Days to Decision 363 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
261d slower than avg
Panel avg: 102d · This submission: 363d
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 K020595.
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