Cleared Traditional

K911362 - AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST

K911362 is an FDA 510(k) clearance for AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM AN..., manufactured by Amico Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K911362 · Amico Laboratories, Inc. · Microbiology device
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Oct 1991
Decision
193d
Days
Class 1
Risk

K911362 is an FDA 510(k) clearance for the AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Amico Laboratories, Inc. (Nashville, US). The FDA issued a Cleared decision on October 7, 1991 after a review of 193 days - an extended review 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: 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 Amico Laboratories, Inc. devices

FDA 510(k) Submission Details - K911362

510(k) Number K911362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date October 07, 1991
Days to Decision 193 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 102d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

LJN Device Classification - Class 1, General Controls

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 17
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K911362.
IMMUNOWELL VCA IGM TEST
K973939 · Genbio · Aug 1998
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 IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
EBV VCA ANTIBODY (IGM)
K896594 · Hillcrest Biologicals · Jan 1990
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639 · Diagnostic Technology, Inc. · Jun 1989