Cleared Special

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K183223 · Diasorin Molecular, LLC · Microbiology

Dec 2018

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K183223 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 December 19, 2018, 29 days after receiving the submission on November 20, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K183223 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2018
Decision Date	December 19, 2018
Days to Decision	29 days
Submission Type	Special
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.