Cleared Special

BIOPLEX 2200 TORC IGG

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

About This 510(k) Submission

K120572 is an FDA 510(k) clearance for the BIOPLEX 2200 TORC IGG, a Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv (Class II — Special Controls, product code OMI), submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on March 26, 2012, 28 days after receiving the submission on February 27, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K120572 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code OMI — Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Device Class Class II — 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.