Cleared Traditional

K853307 - DIRECT ELISA FOR HERPES SIMPLEX VIRUS

K853307 is the FDA 510(k) clearance for DIRECT ELISA FOR HERPES SIMPLEX VIRUS by Fairleigh Dickinson Laboratories, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 K853307.
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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