Cleared Traditional

VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)

K140083 · Nanosphere, Inc. · Microbiology

Jun 2014

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K140083 is an FDA 510(k) clearance for the VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP), a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCH), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on June 20, 2014, 158 days after receiving the submission on January 13, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K140083 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2014
Decision Date	June 20, 2014
Days to Decision	158 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.