510(k) K132200
K132200 is an FDA 510(k) premarket notification submitted by Gen-Probe Prodesse, Inc. for the device "PRO HMPV+ ASSAY". The FDA issued a decision of Substantially Equivalent on August 14, 2013. The device falls under product code OEM (Human Metapneumovirus (Hmpv) Rna Assay System), a Class II device regulated under 21 CFR 866.3980. Gen-Probe Prodesse, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2013
- Date Received
- July 16, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Human Metapneumovirus (Hmpv) Rna Assay System
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
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.