Cleared Traditional

Great Basin Shiga Toxin Direct Test

K152955 · Great Basin Scientific, Inc. · Microbiology

Mar 2016

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K152955 is an FDA 510(k) clearance for the Great Basin Shiga Toxin Direct Test, a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCH), submitted by Great Basin Scientific, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 22, 2016, 167 days after receiving the submission on October 7, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K152955 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 2015
Decision Date	March 22, 2016
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3990
Definition	A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial 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.