Lyra RSV+hMPV Assay
FDA 510(k) K230349 · Quidel Corporation
510(k) numberK230349
Submission
- Device name
- Lyra RSV+hMPV Assay
- Applicant
- Quidel Corporation
San Diego, CA, US - Received
- February 9, 2023
- Decision date
- March 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OEM – Human Metapneumovirus (Hmpv) Rna Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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.
Other 510(k)s with product code OEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132200 | Pro Hmpv+ AssayOEM · Special | Gen-Probe Prodesse, Inc. | 08/14/2013SE |
| K122189 | Quidel Molecular RSV + HMPV AssayOEM · Traditional | Quidel Corp. | 03/08/2013SE |
| K123838 | Pro Hmpv+ AssayOEM · Special | Gen-Probe Prodesse, Inc. | 01/16/2013SE |
| K112490 | Quidel Molecular HMPV AssayOEM · Traditional | Quidel Corp. | 12/15/2011SE |
| K082688 | Pro Hmpv+ AssayOEM · Traditional | Prodesse, Inc. | 11/07/2008SE |
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Questions and answers
When was Lyra RSV+hMPV Assay cleared by the FDA?
Lyra RSV+hMPV Assay (K230349) received a 510(k) decision of Substantially Equivalent on March 10, 2023, 29 days after the submission was received.
What is the product code of K230349?
The FDA product code is OEM – Human Metapneumovirus (Hmpv) Rna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.