Cleared Traditional

K853307 - DIRECT ELISA FOR HERPES SIMPLEX VIRUS

K853307 is an FDA 510(k) clearance for DIRECT ELISA FOR HERPES SIMPLEX VIRUS, manufactured by Fairleigh Dickinson Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K853307 · Fairleigh Dickinson Laboratories, Inc. · Microbiology device
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Dec 1985
Decision
138d
Days
Class 2
Risk

K853307 is an FDA 510(k) clearance for the DIRECT ELISA FOR HERPES SIMPLEX VIRUS. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Fairleigh Dickinson Laboratories, Inc. (Abilene, US). The FDA issued a Cleared decision on December 23, 1985 after a review of 138 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 Fairleigh Dickinson Laboratories, Inc. devices

FDA 510(k) Submission Details - K853307

510(k) Number K853307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1985
Decision Date December 23, 1985
Days to Decision 138 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 102d · This submission: 138d
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 K853307.
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436 · Syva Co. · Feb 1988
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
K870602 · Boots-Celltech Diagnostics, Inc. · May 1987
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
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · Cordis Corp. · Apr 1985