Cleared Traditional

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

K080008 · Bio-Rad Laboratories, Inc. · Microbiology
Feb 2009
Decision
418d
Days
Class 2
Risk

About This 510(k) Submission

K080008 is an FDA 510(k) clearance for the BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET, a Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv (Class II — Special Controls, product code OMI), submitted by Bio-Rad Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 23, 2009, 418 days after receiving the submission on January 2, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K080008 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2008
Decision Date February 23, 2009
Days to Decision 418 days
Submission Type Traditional
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.