Cleared Traditional

K880604 - COLORGENE HSV DNA HYBRIDIZATION TEST

K880604 is an FDA 510(k) clearance for COLORGENE HSV DNA HYBRIDIZATION TEST, manufactured by Enzo Biochem, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K880604

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.

GQN Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K880604.
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
WELLCOZYME HSV WZO2
K875311 · Wellcome Diagnostics · Aug 1988
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
K880996 · Whittaker Bioproducts, Inc. · May 1988
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
K881180 · Whittaker Bioproducts, Inc. · May 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988