Cleared Special

PRO HMPV+ ASSAY

K132200 · Gen-Probe Prodesse, Inc. · Microbiology
Aug 2013
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K132200 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 Gen-Probe Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 14, 2013, 29 days after receiving the submission on July 16, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K132200 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2013
Decision Date August 14, 2013
Days to Decision 29 days
Submission Type Special
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.