Quidel Molecular HMPV Assay
FDA 510(k) K112490 · Quidel Corp.
510(k) numberK112490
Submission
- Device name
- Quidel Molecular HMPV Assay
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- August 29, 2011
- Decision date
- December 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K230349 | Lyra RSV+hMPV AssayOEM · Special | Quidel Corporation | 03/10/2023SE |
| 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 |
| K082688 | Pro Hmpv+ AssayOEM · Traditional | Prodesse, Inc. | 11/07/2008SE |
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| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
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Questions and answers
When was Quidel Molecular HMPV Assay cleared by the FDA?
Quidel Molecular HMPV Assay (K112490) received a 510(k) decision of Substantially Equivalent on December 15, 2011, 108 days after the submission was received.
What is the product code of K112490?
The FDA product code is OEM – Human Metapneumovirus (Hmpv) Rna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.