K080008 is an FDA 510(k) clearance for the BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3510. 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..
| 510(k) Number | K080008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |