Cleared Traditional

K880604 - COLORGENE HSV DNA HYBRIDIZATION TEST

K880604 is the FDA 510(k) clearance for COLORGENE HSV DNA HYBRIDIZATION TEST by Enzo Biochem, Inc.. It is a Class 2 Microbiology device (product code GQN) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K880604 · Enzo Biochem, Inc. · Microbiology device
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Aug 1988
Decision
173d
Days
Class 2
Risk

K880604 is an FDA 510(k) clearance for the COLORGENE HSV DNA HYBRIDIZATION TEST. 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 August 3, 1988 after a review of 173 days - an extended review cycle.

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 K880604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1988
Decision Date August 03, 1988
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 102d · This submission: 173d
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 K880604.
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345 · Diagnostic Hybrids, Inc. · Jun 1991
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
K884761 · Difco Laboratories, Inc. · Dec 1988
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