510(k) K173498

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack by Diasorin Molecular, LLC — Product Code OZZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 13, 2018
Date Received: November 13, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bordetella Pertussis Dna Assay System
Device Class: Class II
Regulation Number: 866.3980
Review Panel: MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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Other clearances for product code OZZ

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K170284 — Great Basin Bordetella Direct Test (March 31, 2017)
K152285 — illumigene Pertussis DNA Amplification Assay (November 10, 2015)
K143206 — AmpliVue Bordetella Assay (December 10, 2014)
K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTR (March 25, 2014)