Cleared Traditional

QUIDEL MOLECULAR HMPV ASSAY

K112490 · Quidel Corp. · Microbiology

Dec 2011

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K112490 is an FDA 510(k) clearance for the QUIDEL MOLECULAR 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 December 15, 2011, 108 days after receiving the submission on August 29, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K112490 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2011
Decision Date	December 15, 2011
Days to Decision	108 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.