Cleared Traditional

WELLCOZYME HSV WZO2 (K875311) - FDA 510(k) Clearance

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

K875311 · Wellcome Diagnostics · Microbiology device
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Aug 1988
Decision
218d
Days
Class 2
Risk

K875311 is an FDA 510(k) clearance for the WELLCOZYME HSV WZO2. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on August 3, 1988 after a review of 218 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 Wellcome Diagnostics devices

Submission Details

510(k) Number K875311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date August 03, 1988
Days to Decision 218 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 102d · This submission: 218d
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 K875311.
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