Cleared Traditional

Great Basin Bordetella Direct Test

K170284 · Great Basin Scientific, Inc. · Microbiology

Mar 2017

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K170284 is an FDA 510(k) clearance for the Great Basin Bordetella Direct Test, a Bordetella Pertussis Dna Assay System (Class II — Special Controls, product code OZZ), submitted by Great Basin Scientific, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 31, 2017, 60 days after receiving the submission on January 30, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K170284 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2017
Decision Date	March 31, 2017
Days to Decision	60 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.