Cleared Traditional

D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT

K091171 · Diagnostic Hybrids, Inc. · Microbiology
Sep 2009
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K091171 is an FDA 510(k) clearance for the D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT, a Antisera, Fluorescent, Human Metapneumovirus (Class II — Special Controls, product code OMG), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 11, 2009, 142 days after receiving the submission on April 22, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K091171 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2009
Decision Date September 11, 2009
Days to Decision 142 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.