Cleared Special

K111072 - BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K111072 · Bio-Rad Laboratories · Microbiology device
Aug 2011
Decision
127d
Days
Class 2
Risk

K111072 is an FDA 510(k) clearance for the BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOP.... Classified as Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (product code OPL), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on August 23, 2011 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K111072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date August 23, 2011
Days to Decision 127 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 174d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
Definition The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human Igg Antibodies To Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (vzv) In Human Serum And/ Or Plasma. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient¿s Serological Status To Measles Virus, Mumps Virus, Rubella And Vzv. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors.
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.