Cleared Traditional

BIOPLEX 2200 EBV IGM KIT (K123021) - FDA 510(k) Clearance

Class I Microbiology device.

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.

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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
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.