Cleared Traditional

K120959 - BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120959 · Bio-Rad Laboratories · Microbiology device
Jun 2012
Decision
84d
Days
Class 2
Risk

K120959 is an FDA 510(k) clearance for the BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on June 22, 2012 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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 K120959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date June 22, 2012
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 174d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.