Cleared Traditional

K894622 - VARICELLA ZOSTER VIRUS

K894622 is an FDA 510(k) clearance for VARICELLA ZOSTER VIRUS, manufactured by Bion Ent., Ltd.. The device is a Class 2 Microbiology device with product code GQW cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K894622 · Bion Ent., Ltd. · Microbiology device
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Oct 1989
Decision
96d
Days
Class 2
Risk

K894622 is an FDA 510(k) clearance for the VARICELLA ZOSTER VIRUS. Classified as Antigen, Cf, (including Cf Control), Varicella-zoster (product code GQW), Class II - Special Controls.

Submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 Bion Ent., Ltd. devices

FDA 510(k) Submission Details - K894622

510(k) Number K894622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date October 24, 1989
Days to Decision 96 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQW Device Classification - Class 2, Special Controls

Product Code GQW Antigen, Cf, (including Cf Control), Varicella-zoster
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3900
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 - GQW Antigen, Cf, (including Cf Control), Varicella-zoster

Devices cleared under the same product code (GQW) and FDA review panel - the closest regulatory comparables to K894622.
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · Light Diagnostics · Oct 1999
VZV ANTIGEN CONTROL SLIDES
K964872 · Viral Antigens, Inc. · Mar 1997
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1991
VARICELLA-ZOSTER(IGG) IFA TEST
K841434 · Zeus Scientific, Inc. · Apr 1985
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · Orion Diagnostica, Inc. · Dec 1980