Cleared Traditional

K863317 - ENZYGNOST ANTI-VZV IGG TEST

K863317 is the FDA 510(k) clearance for ENZYGNOST ANTI-VZV IGG TEST by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (product code GQX) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K863317 · Behring Diagnostics, Inc. · Microbiology device
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Apr 1987
Decision
239d
Days
Class 2
Risk

K863317 is an FDA 510(k) clearance for the ENZYGNOST ANTI-VZV IGG TEST. Classified as Antiserum, Cf, Varicella-zoster (product code GQX), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on April 22, 1987 after a review of 239 days - an extended review 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: 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K863317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1986
Decision Date April 22, 1987
Days to Decision 239 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
137d slower than avg
Panel avg: 102d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQX Antiserum, Cf, 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 - GQX Antiserum, Cf, Varicella-zoster

Devices cleared under the same product code (GQX) and FDA review panel - the closest regulatory comparables to K863317.
VZV IGM TEST
K911301 · Gull Laboratories, Inc. · Jul 1991
VZV TEST
K875358 · Gull Laboratories, Inc. · Mar 1988
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
K841526 · Ortho Diagnostic Systems, Inc. · Jun 1984
VARICELLA-ZOSTER FA LABELLED (8-321 RF)
K770806 · Flow Laboratories, Inc. · May 1977
VARICELLA-ZOSTER FA LABELED PRESERUM
K770810 · Flow Laboratories, Inc. · May 1977