Cleared Traditional

K872576 - COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

K872576 is an FDA 510(k) clearance for COLORGENE DNA HYBRIDIZATION TEST CMV CO..., manufactured by Enzo Biochem, Inc.. The device is a Class 2 Microbiology device with product code GQH cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K872576 · Enzo Biochem, Inc. · Microbiology device
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Dec 1987
Decision
157d
Days
Class 2
Risk

K872576 is an FDA 510(k) clearance for the COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Enzo Biochem, Inc. (New York, US). The FDA issued a Cleared decision on December 4, 1987 after a review of 157 days - an extended review cycle.

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 Enzo Biochem, Inc. devices

FDA 510(k) Submission Details - K872576

510(k) Number K872576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1987
Decision Date December 04, 1987
Days to Decision 157 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 102d · This submission: 157d
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 12
Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K872576.
FITC MURINE MONOCLONAL ANTI-CMV IGG
K882024 · Whittaker Bioproducts, Inc. · Aug 1988
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
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
K864565 · Serono Diagnostics, Inc. · Feb 1987
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · Clinical Sciences, Inc. · May 1984