Cleared Traditional

QUIDEL MOLECULAR RSV + HMPV ASSAY

K122189 · Quidel Corp. · Microbiology

Mar 2013

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K122189 is an FDA 510(k) clearance for the QUIDEL MOLECULAR RSV + HMPV ASSAY, a Human Metapneumovirus (hmpv) Rna Assay System (Class II — Special Controls, product code OEM), submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on March 8, 2013, 227 days after receiving the submission on July 24, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K122189 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2012
Decision Date	March 08, 2013
Days to Decision	227 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.