Cleared Traditional

K922331 - BARTELS EPSTEIN-BARR VIRUS IGM EIA

K922331 is the FDA 510(k) clearance for BARTELS EPSTEIN-BARR VIRUS IGM EIA by Baxter Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LJN) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K922331 · Baxter Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
112d
Days
Class 1
Risk

K922331 is an FDA 510(k) clearance for the BARTELS EPSTEIN-BARR VIRUS IGM EIA. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 112 days - within the typical 510(k) review window.

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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K922331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date September 02, 1992
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
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 K922331.
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
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
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
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