Cleared Traditional

LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124

K093815 · Millipore Corporation · Microbiology
Mar 2010
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K093815 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124, a Antisera, Fluorescent, Human Metapneumovirus (Class II — Special Controls, product code OMG), submitted by Millipore Corporation (Temecula, US). The FDA issued a Cleared decision on March 12, 2010, 88 days after receiving the submission on December 14, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K093815 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2009
Decision Date March 12, 2010
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OMG — Antisera, Fluorescent, Human Metapneumovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3980
Definition It Is Intended For The Qualitative Detection And Identification Of Human Metapneumovirus (hmpv) In Direct Respiratory Specimens Or Cell Culture. The Assay Detects Hmpv Antigens By Immunofluorescence Using Antibodies, From Patients With Signs And Symptoms Of Acute Respiratory Infection. This Assay Detects But Is Not Intended To Differentiate The Four Recognized Genetic Sub-lineages Of Hmpv.