Cleared Traditional

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K173498 · Diasorin Molecular, LLC · Microbiology

Aug 2018

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K173498 is an FDA 510(k) clearance for the Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack, a Bordetella Pertussis Dna Assay System (Class II — Special Controls, product code OZZ), submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on August 13, 2018, 273 days after receiving the submission on November 13, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K173498 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2017
Decision Date	August 13, 2018
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZZ — Bordetella Pertussis Dna Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	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.