Cleared Traditional

D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

K093233 · Diagnostic Hybrids, Inc. · Microbiology
Dec 2009
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K093233 is an FDA 510(k) clearance for the D3 FASTPOINT L-DFA RSV/MVP 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 December 4, 2009, 51 days after receiving the submission on October 14, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K093233 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2009
Decision Date December 04, 2009
Days to Decision 51 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.