Cleared Traditional

K875311 - WELLCOZYME HSV WZO2

K875311 is an FDA 510(k) clearance for WELLCOZYME HSV WZO2, manufactured by Wellcome Diagnostics. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K875311 · Wellcome Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K875311

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
Combination Product No
PCCP Authorized No
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.

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 22
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K875311.
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345 · Diagnostic Hybrids, Inc. · Jun 1991
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
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