Cleared Traditional

K875358 - VZV TEST

K875358 is an FDA 510(k) clearance for VZV 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 91-day FDA review.

K875358 · Gull Laboratories, Inc. · Microbiology device
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Mar 1988
Decision
91d
Days
Class 2
Risk

K875358 is an FDA 510(k) clearance for the VZV 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 March 31, 1988 after a review of 91 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.

FDA 510(k) Submission Details - K875358

510(k) Number K875358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date March 31, 1988
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
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

All 10
Devices cleared under the same product code (GQX) and FDA review panel - the closest regulatory comparables to K875358.
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · Light Diagnostics · Mar 1996
VZV IGM TEST
K911301 · Gull Laboratories, Inc. · Jul 1991
VIRGO(R) VZV-IGG ELISA
K883427 · Electro-Nucleonics, Inc. · Mar 1989
ENZYGNOST ANTI-VZV IGG TEST
K863317 · Behring Diagnostics, Inc. · Apr 1987
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
K853540 · Idt, A Division of Whittaker M.A. Bioproducts · Feb 1986
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
K852930 · Microbix Biosystems, Inc. · Nov 1985
K875358 · VZV TEST
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