Cleared Special

K120572 - BIOPLEX 2200 TORC IGG (FDA 510(k) Clearance)

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

K120572 · Bio-Rad Laboratories, Inc. · Microbiology device
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Mar 2012
Decision
28d
Days
Class 2
Risk

K120572 is an FDA 510(k) clearance for the BIOPLEX 2200 TORC IGG. Classified as Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv (product code OMI), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on March 26, 2012 after a review of 28 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K120572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2012
Decision Date March 26, 2012
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
Definition The Kit Is A Multiplex Immunoassay Intended For The Quantitative Detection Of Igg Antibodies To Toxoplasma Gondii (t. Gondii) And Rubella, And Qualitative Detection Of Cytomegalovirus (cmv) Igg In Human Serum And/ Or Plasma. Indicated As An Aid In The Determination Of Serological Status To T. Gondii, Rubella And Cmv. This Kit 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.