Cleared Traditional

K120959 - BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

K120959 is the FDA 510(k) clearance for BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT by Bio-Rad Laboratories. It is a Class 2 Microbiology device (product code MXJ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K120959 · Bio-Rad Laboratories · Microbiology device
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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.

View all Bio-Rad Laboratories devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 102d · 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.

Regulatory Peers - MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

All 9
Devices cleared under the same product code (MXJ) and FDA review panel - the closest regulatory comparables to K120959.
Elecsys HSV-1 IgG (08948844160)
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ADVIA Centaur Herpes-1 IgG
K181333 · Biokit, S.A. · Aug 2018
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · Roche Diagnostics · Jul 2012
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
K103363 · Zeus Scientific, Inc. · Apr 2011
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K090409 · Bio-Rad Laboratories · May 2009
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685 · DiaSorin, Inc. · Nov 2008