Cleared Traditional

K874078 - MERITEC(TM)-GC

K874078 is an FDA 510(k) clearance for MERITEC(TM)-GC, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LIC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K874078 · Meridian Diagnostics, Inc. · Microbiology device
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Dec 1987
Decision
64d
Days
Class 2
Risk

K874078 is an FDA 510(k) clearance for the MERITEC(TM)-GC. Classified as Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae (product code LIC), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 9, 1987 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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 - K874078

510(k) Number K874078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1987
Decision Date December 09, 1987
Days to Decision 64 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
38d faster than avg
Panel avg: 102d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIC Device Classification - Class 2, Special Controls

Product Code LIC Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LIC Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae

All 8
Devices cleared under the same product code (LIC) and FDA review panel - the closest regulatory comparables to K874078.
PHADEBACT MONOCLONAL GC TEST, MODIFICATION
K921075 · Karo Bio Diagnostics AB · May 1992
IDEIA(TM) CHLAMYDIA, MODIFICATION
K911430 · Novo Nordisk Diagnostics, Ltd. · Aug 1991
G-MARK
K880076 · Bainbridge Laboratories, Inc. · Jul 1988
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
K871105 · New Horizons Diagnostics Co. · May 1987
PHADEBACT MONOCLONAL GC OMNI TEST
K851650 · Pharmacia, Inc. · Jul 1985
PHADEBACT MONOCLONAL GC TEST
K850351 · Pharmacia, Inc. · Mar 1985
K874078 · MERITEC(TM)-GC
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