Cleared Traditional

K892263 - MERIFLUOR(TM) -TRICHOMONAS

K892263 is an FDA 510(k) clearance for MERIFLUOR(TM) -TRICHOMONAS, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JWZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K892263 · Meridian Diagnostics, Inc. · Microbiology device
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May 1989
Decision
50d
Days
Class 1
Risk

K892263 is an FDA 510(k) clearance for the MERIFLUOR(TM) -TRICHOMONAS. Classified as Kit, Screening, Trichomonas (product code JWZ), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 24, 1989 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K892263

510(k) Number K892263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1989
Decision Date May 24, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 102d · This submission: 50d
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

All 10
Devices cleared under the same product code (JWZ) and FDA review panel - the closest regulatory comparables to K892263.
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT
K020226 · Hellen Professional Services · Aug 2002
MERIVIEW TM TRICHOMONAS
K894246 · Meridian Diagnostics, Inc. · Aug 1989
SUPER DUO
K892802 · Mercia Diagnostics , Ltd. · Jun 1989
TRICHOMATE(R) SUPER
K875138 · Mercia Diagnostics , Ltd. · May 1988
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
K874259 · California Integrated Diagnostics, Inc. · Dec 1987
MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT
K871279 · California Integrated Diagnostics, Inc. · Apr 1987
K892263 · MERIFLUOR(TM) -TRICHOMONAS
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