Cleared Traditional

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

Class I Microbiology device.

K123021 · Bio-Rad Laboratories · Microbiology device
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.

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
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 174d · 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.