K202755 is an FDA 510(k) clearance for the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack. This device is classified as a Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection (Class II - Special Controls, product code QDZ).
Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on November 5, 2022, 775 days after receiving the submission on September 21, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3181. The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies..
| 510(k) Number | K202755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2020 |
| Decision Date | November 05, 2022 |
| Days to Decision | 775 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QDZ - Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3181 |
| Definition | The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies. |