Cleared Traditional

K941046 - VZV IGG ELISA TEST

K941046 is an FDA 510(k) clearance for VZV IGG ELISA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LFY cleared through the Traditional 510(k) pathway after a 535-day FDA review.

K941046 · Gull Laboratories, Inc. · Microbiology device
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Aug 1995
Decision
535d
Days
Class 2
Risk

K941046 is an FDA 510(k) clearance for the VZV IGG ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (product code LFY), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 535 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K941046

510(k) Number K941046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date August 24, 1995
Days to Decision 535 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
433d slower than avg
Panel avg: 102d · This submission: 535d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFY Device Classification - Class 2, Special Controls

Product Code LFY Enzyme Linked Immunoabsorbent Assay, 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 - LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

All 13
Devices cleared under the same product code (LFY) and FDA review panel - the closest regulatory comparables to K941046.
SERAQUEST VZV IGG
K972295 · Quest Intl., Inc. · Nov 1997
VZV IGG ELISA TEST SYSTEM
K961012 · Zeus Scientific, Inc. · Jul 1996
VARICELISA, MODIFICATION
K943843 · Biowhittaker Molecular Applications, Inc. · Mar 1996
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K923122 · Biomerieux Vitek, Inc. · Oct 1992
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
K900688 · Clinical Sciences, Inc. · May 1990
VZV MICROASSAY
K890642 · Diamedix Corp. · May 1989