510(k) K093233
K093233 is an FDA 510(k) premarket notification submitted by Diagnostic Hybrids, Inc. for the device "D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code OMG (Antisera, Fluorescent, Human Metapneumovirus), a Class II device regulated under 21 CFR 866.3980. Diagnostic Hybrids, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2009
- Date Received
- October 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.