Human Metapneumovirus (Hmpv) Rna Assay System
The Human Metapneumovirus (hMPV) RNA Assay System (product code OEM) is a microbiology in vitro diagnostic device that qualitatively detects hMPV RNA extracted from human respiratory specimens or viral cultures, aiding in the diagnosis of respiratory hMPV infection in conjunction with clinical and laboratory findings in patients with signs and symptoms of upper respiratory tract infections. Human metapneumovirus is a significant cause of respiratory illness in children and immunocompromised adults. This device is FDA Class 2 under regulation 866.3980 in the Microbiology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEM
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230349 | Lyra RSV+hMPV Assay | Mar 10, 2023 | Substantially Equivalent | Quidel Corporation |
| K132200 | PRO HMPV+ ASSAY | Aug 14, 2013 | Substantially Equivalent | Gen-Probe Prodesse, Inc. |
| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Mar 08, 2013 | Substantially Equivalent | Quidel Corp. |
| K123838 | PRO HMPV+ ASSAY | Jan 16, 2013 | Substantially Equivalent | Gen-Probe Prodesse, Inc. |
| K112490 | QUIDEL MOLECULAR HMPV ASSAY | Dec 15, 2011 | Substantially Equivalent | Quidel Corp. |
| K082688 | PRO HMPV+ ASSAY | Nov 07, 2008 | Substantially Equivalent | Prodesse, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.