Cleared Traditional

K912239 - VZVSCAN(TM) LATEX AGGUTINATION TEST

K912239 is an FDA 510(k) clearance for VZVSCAN(TM) LATEX AGGUTINATION TEST, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code GQW cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K912239 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jun 1991
Decision
21d
Days
Class 2
Risk

K912239 is an FDA 510(k) clearance for the VZVSCAN(TM) LATEX AGGUTINATION TEST. Classified as Antigen, Cf, (including Cf Control), Varicella-zoster (product code GQW), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 11, 1991 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K912239

510(k) Number K912239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date June 11, 1991
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
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 K912239.
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206 · Diagnostic Hybrids, Inc. · Aug 2007
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · Light Diagnostics · Oct 1999
VZV ANTIGEN CONTROL SLIDES
K964872 · Viral Antigens, Inc. · Mar 1997
VARICELLA-ZOSTER(IGG) IFA TEST
K841434 · Zeus Scientific, Inc. · Apr 1985
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · Orion Diagnostica, Inc. · Dec 1980