510(k) K132200

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.