Cleared Special

PRO HMPV+ ASSAY

K123838 · Gen-Probe Prodesse, Inc. · Microbiology

Jan 2013

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K123838 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 January 16, 2013, 34 days after receiving the submission on December 13, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K123838 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2012
Decision Date	January 16, 2013
Days to Decision	34 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.