Cleared Traditional

K841434 - VARICELLA-ZOSTER(IGG) IFA TEST

K841434 is an FDA 510(k) clearance for VARICELLA-ZOSTER(IGG) IFA TEST, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code GQW cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K841434 · Zeus Scientific, Inc. · Microbiology device
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Apr 1985
Decision
378d
Days
Class 2
Risk

K841434 is an FDA 510(k) clearance for the VARICELLA-ZOSTER(IGG) IFA TEST. Classified as Antigen, Cf, (including Cf Control), Varicella-zoster (product code GQW), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 19, 1985 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K841434

510(k) Number K841434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date April 19, 1985
Days to Decision 378 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
276d slower than avg
Panel avg: 102d · This submission: 378d
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 K841434.
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206 · Diagnostic Hybrids, Inc. · Aug 2007
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1991
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · Orion Diagnostica, Inc. · Dec 1980