Cleared Traditional

K033864 - GENZYME OSOM TRICHOMONAS RAPID TEST

K033864 is an FDA 510(k) clearance for GENZYME OSOM TRICHOMONAS RAPID TEST, manufactured by Genzyme Corp.. The device is a Class 1 Microbiology device with product code JWZ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K033864 · Genzyme Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
112d
Days
Class 1
Risk

K033864 is an FDA 510(k) clearance for the GENZYME OSOM TRICHOMONAS RAPID TEST. Classified as Kit, Screening, Trichomonas (product code JWZ), Class I - General Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on April 2, 2004 after a review of 112 days - within the typical 510(k) review window.

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.

View all Genzyme Corp. devices

FDA 510(k) Submission Details - K033864

510(k) Number K033864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2003
Decision Date April 02, 2004
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
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 K033864.
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