Cleared Traditional

K091616 - BIOPLEX 2200 MMRV IGG (FDA 510(k) Clearance)

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

K091616 · Bio-Rad Laboratories · Microbiology device
Mar 2010
Decision
299d
Days
Class 2
Risk

K091616 is an FDA 510(k) clearance for the BIOPLEX 2200 MMRV IGG. 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 (Redmond, US). The FDA issued a Cleared decision on March 29, 2010 after a review of 299 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K091616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date March 29, 2010
Days to Decision 299 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 174d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.