Cleared Traditional

XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (K020595) - FDA 510(k) Clearance

Class I Microbiology device.

K020595 · Xenotope Diagnostics, Inc. · Microbiology device
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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

Submission Details

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.

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.