510(k) K093815
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2010
- Date Received
- December 14, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Human Metapneumovirus
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.