Cleared Traditional

K864565 - MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT

K864565 is an FDA 510(k) clearance for MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT, manufactured by Serono Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GQH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K864565 · Serono Diagnostics, Inc. · Microbiology device
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Feb 1987
Decision
92d
Days
Class 2
Risk

K864565 is an FDA 510(k) clearance for the MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 Serono Diagnostics, Inc. devices

FDA 510(k) Submission Details - K864565

510(k) Number K864565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date February 19, 1987
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQH Device Classification - Class 2, Special Controls

Product Code GQH Antigen, Cf (including Cf Control), Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 - GQH Antigen, Cf (including Cf Control), Cytomegalovirus

All 11
Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K864565.
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · Ortho Diagnostic Systems, Inc. · Aug 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · Syva Co. · Apr 1988
CYTOMEGALOVIRUS CONTROL SLIDES
K873114 · Medical Diagnostic Technologies, Inc. · Sep 1987
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · Clinical Sciences, Inc. · May 1984
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · Zeus Scientific, Inc. · Sep 1981
CYTOMEGALO VIRUS & CONTROLS
K802930 · Orion Diagnostica, Inc. · Jan 1981