Cleared Traditional

Solana Bordetella Complete Assay

K181029 · Quidel Corporation · Microbiology

Jul 2018

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K181029 is an FDA 510(k) clearance for the Solana Bordetella Complete Assay, a Bordetella Pertussis Dna Assay System (Class II — Special Controls, product code OZZ), submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on July 15, 2018, 88 days after receiving the submission on April 18, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K181029 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2018
Decision Date	July 15, 2018
Days to Decision	88 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.