Cleared Traditional

K872576 - COLORGENE DNA HYBRIDIZATION TEST CMV CO...

K872576 is the FDA 510(k) clearance for COLORGENE DNA HYBRIDIZATION TEST CMV CO... by Enzo Biochem, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K872576.
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 TEST SYSTEM
K811671 · Zeus Scientific, Inc. · Sep 1981