Cleared Traditional

PRO HMPV+ ASSAY

K082688 · Prodesse, Inc. · Microbiology
Nov 2008
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K082688 is an FDA 510(k) clearance for the PRO HMPV+ ASSAY, a Human Metapneumovirus (hmpv) Rna Assay System (Class II — Special Controls, product code OEM), submitted by Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 7, 2008, 53 days after receiving the submission on September 15, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K082688 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2008
Decision Date November 07, 2008
Days to Decision 53 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OEM — Human Metapneumovirus (hmpv) Rna Assay System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3980
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.