Cleared Traditional

K870733 - COLORGENE DNA HYBRIDIZATION TEST FOR HS...

K870733 is the FDA 510(k) clearance for COLORGENE DNA HYBRIDIZATION TEST FOR HS... by Enzo Biochem, Inc.. It is a Class 2 Microbiology device (product code GQN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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 16
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K870733.
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
K873529 · Diagnostic Hybrids, Inc. · Aug 1988
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
ORTHO HSV ANTIGEN ELISA TEST
K854488 · Ortho Diagnostic Systems, Inc. · Feb 1986
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · Bartels Immunodiagnostic Supplies, Inc. · Nov 1985
HERPES SIMPLEX GROUP CF ANTIGEN
K850609 · Hillcrest Biologicals · May 1985