Cleared Traditional

H. SIMPLEX VIRUS (K843658) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843658 · Institute Virion , Ltd. · Microbiology device
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Sep 1985
Decision
374d
Days
Class 2
Risk

K843658 is an FDA 510(k) clearance for the H. SIMPLEX VIRUS. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Institute Virion , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Institute Virion , Ltd. devices

Submission Details

510(k) Number K843658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date September 26, 1985
Days to Decision 374 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 102d · This submission: 374d
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 33
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K843658.
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
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · Cordis Corp. · Apr 1985
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · Syva Co. · Jun 1984
CORDIA HS
K832875 · Cordis Corp. · Nov 1983