Cleared Traditional

K140083 - VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140083 · Nanosphere, Inc. · Microbiology device
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Jun 2014
Decision
158d
Days
Class 2
Risk

K140083 is an FDA 510(k) clearance for the VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP). Classified as Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (product code PCH), Class II - Special Controls.

Submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on June 20, 2014 after a review of 158 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3990 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanosphere, Inc. devices

Submission Details

510(k) Number K140083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 102d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

All 36
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