Cleared Traditional

K892802 - SUPER DUO

K892802 is an FDA 510(k) clearance for SUPER DUO, manufactured by Mercia Diagnostics , Ltd.. The device is a Class 1 Microbiology device with product code JWZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K892802 · Mercia Diagnostics , Ltd. · Microbiology device
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Jun 1989
Decision
57d
Days
Class 1
Risk

K892802 is an FDA 510(k) clearance for the SUPER DUO. Classified as Kit, Screening, Trichomonas (product code JWZ), Class I - General Controls.

Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on June 13, 1989 after a review of 57 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.

View all Mercia Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K892802

510(k) Number K892802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date June 13, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 102d · This submission: 57d
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 K892802.
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864 · Genzyme Corp. · Apr 2004
MERIVIEW TM TRICHOMONAS
K894246 · Meridian Diagnostics, Inc. · Aug 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