Cleared Traditional

Great Basin Stool Bacterial Pathogens Panel

K163571 · Great Basin Scientific, Inc. · Microbiology

Jul 2017

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K163571 is an FDA 510(k) clearance for the Great Basin Stool Bacterial Pathogens Panel, a Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCI), submitted by Great Basin Scientific, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 12, 2017, 205 days after receiving the submission on December 19, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K163571 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2016
Decision Date	July 12, 2017
Days to Decision	205 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PCI — Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3990
Definition	A Gastrointestinal Bacterial Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Bacterial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Bacterial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.