Cleared Traditional

K123021 - BIOPLEX 2200 EBV IGM KIT

K123021 is the FDA 510(k) clearance for BIOPLEX 2200 EBV IGM KIT by Bio-Rad Laboratories. It is a Class 1 Microbiology device (product code LJN) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K123021 · Bio-Rad Laboratories · Microbiology device
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Nov 2012
Decision
36d
Days
Class 1
Risk

K123021 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGM KIT. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 36 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 Bio-Rad Laboratories devices

Submission Details

510(k) Number K123021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date November 02, 2012
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
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 8
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K123021.
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
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc. · Sep 1992
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1988