K093784 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM. This device is classified as a Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 (Class II - Special Controls, product code OPM).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 16, 2010, 219 days after receiving the submission on December 9, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510. The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human Igg Antibodies To Toxoplasma Gondii (t.gondii), Rubella, Cytomegalovirus (cmv) And Herpes Simplex Virus 1 & 2 (hsv 1 And Hsv 2) In Human Serum. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient's Serological Status To Toxoplasma Gondii, Rubella, Cmv And Hsv 1 & 2. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors..
| 510(k) Number | K093784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2009 |
| Decision Date | July 16, 2010 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OPM — Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 |
| Device Class | Class II - 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 Toxoplasma Gondii (t.gondii), Rubella, Cytomegalovirus (cmv) And Herpes Simplex Virus 1 & 2 (hsv 1 And Hsv 2) In Human Serum. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient's Serological Status To Toxoplasma Gondii, Rubella, Cmv And Hsv 1 & 2. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors. |