Cleared Traditional

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (K870733) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870733 · Enzo Biochem, Inc. · Microbiology device
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May 1987
Decision
90d
Days
Class 2
Risk

K870733 is an FDA 510(k) clearance for the COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Enzo Biochem, Inc. (New York, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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 K870733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1987
Decision Date May 26, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 33
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K870733.
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436 · Syva Co. · Feb 1988
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · Cordis Corp. · Apr 1985
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · Syva Co. · Jun 1984
CORDIA HS
K832875 · Cordis Corp. · Nov 1983