Cleared Traditional

K911301 - VZV IGM TEST

K911301 is an FDA 510(k) clearance for VZV IGM TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GQX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K911301 · Gull Laboratories, Inc. · Microbiology device
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Jul 1991
Decision
114d
Days
Class 2
Risk

K911301 is an FDA 510(k) clearance for the VZV IGM TEST. Classified as Antiserum, Cf, Varicella-zoster (product code GQX), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 114 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K911301

510(k) Number K911301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date July 17, 1991
Days to Decision 114 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
12d slower than avg
Panel avg: 102d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQX Device Classification - Class 2, Special Controls

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 K911301.
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · Light Diagnostics · Mar 1996
VZV TEST
K875358 · Gull Laboratories, Inc. · Mar 1988
ENZYGNOST ANTI-VZV IGG TEST
K863317 · Behring Diagnostics, Inc. · Apr 1987
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