510(k) K183223

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 19, 2018
Date Received: November 20, 2018
Clearance Type: Special
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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K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (August 13, 2018)
K181029 — Solana Bordetella Complete Assay (July 15, 2018)
K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (May 2, 2017)
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)