K230349 is an FDA 510(k) clearance for the Lyra RSV+hMPV Assay. This device is classified as a Human Metapneumovirus (hmpv) Rna Assay System (Class II - Special Controls, product code OEM).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on March 10, 2023, 29 days after receiving the submission on February 9, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3980. A Qualitative In Vitro Diagnostic Assay Intended To Detect Human Metapneumovirus (hmpv) Rna Extracted From Human Respiratory Specimens Or Viral Cultures. Detection Of Hmpv Rna Aids In The Diagnosis Of Respiratory Hmpv Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infections..
| 510(k) Number | K230349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2023 |
| Decision Date | March 10, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OEM — Human Metapneumovirus (hmpv) Rna Assay System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3980 |
| Definition | A Qualitative In Vitro Diagnostic Assay Intended To Detect Human Metapneumovirus (hmpv) Rna Extracted From Human Respiratory Specimens Or Viral Cultures. Detection Of Hmpv Rna Aids In The Diagnosis Of Respiratory Hmpv Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infections. |