Cleared Traditional

K941198 - EBV LGG ELISA TEST

K941198 is the FDA 510(k) clearance for EBV LGG ELISA TEST by Gull Laboratories, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 527-day FDA review.

K941198 · Gull Laboratories, Inc. · Microbiology device
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Aug 1995
Decision
527d
Days
Class 1
Risk

K941198 is an FDA 510(k) clearance for the EBV LGG ELISA TEST. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 23, 1995 after a review of 527 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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

Submission Details

510(k) Number K941198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date August 23, 1995
Days to Decision 527 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
425d slower than avg
Panel avg: 102d · This submission: 527d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LSE Epstein-barr Virus, Other

All 23
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K941198.
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · Zeus Scientific, Inc. · Aug 1998
EBV-VCA IGM ELISA TEST STSTEM
K944449 · Zeus Scientific, Inc. · Sep 1995
EBV-EA(D) IGG ELISA TEST
K940093 · Gull Laboratories, Inc. · Sep 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157 · Incstar Corp. · Jun 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · Incstar Corp. · Jun 1995
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · Ortho Diagnostic Systems, Inc. · Nov 1993