Cleared Traditional

K910042 - EBV IGM ELISA TEST

K910042 is the FDA 510(k) clearance for EBV IGM ELISA TEST by Gull Laboratories, Inc.. It is a Class 1 Microbiology device (product code LJN) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K910042 · Gull Laboratories, Inc. · Microbiology device
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Feb 1991
Decision
48d
Days
Class 1
Risk

K910042 is an FDA 510(k) clearance for the EBV IGM ELISA TEST. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gull Laboratories, Inc. devices

Submission Details

510(k) Number K910042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1991
Decision Date February 21, 1991
Days to Decision 48 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
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJN Antibody Igm, If, Epstein-barr Virus
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 - LJN Antibody Igm, If, Epstein-barr Virus

All 10
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K910042.
COPALIS EBV-M ANTIBODY ASSAY
K991459 · DiaSorin, Inc. · May 1999
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · Ortho Diagnostic Systems, Inc. · Jul 1993
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc. · Sep 1992
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · Immuno Concepts, Inc. · Aug 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886 · Immuno Concepts, Inc. · Aug 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1988