Cleared Traditional

K152386 - NxTAG Respiratory Pathogen Panel

K152386 is an FDA 510(k) clearance for NxTAG Respiratory Pathogen Panel, manufactured by Luminex Molecular Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code OCC cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K152386 · Luminex Molecular Diagnostics, Inc. · Microbiology device
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Dec 2015
Decision
115d
Days
Class 2
Risk

K152386 is an FDA 510(k) clearance for the NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYN.... Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 17, 2015 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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 Luminex Molecular Diagnostics, Inc. devices

FDA 510(k) Submission Details - K152386

510(k) Number K152386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2015
Decision Date December 17, 2015
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

OCC Device Classification - Class 2, Special Controls

Product Code OCC Respiratory Virus Panel Nucleic Acid Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01787227 Completed Observational Industry-sponsored

A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel

A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection

1500
Patients (actual)
4
Sites
Condition studied Respiratory Tract Infection; Bronchitis; Bronchiolitis; Pneumonia
Eligibility All sexes
Principal investigator Jeremy Liu, Ph.D
Sponsor Luminex Molecular Diagnostics (industry)
Started 2015-01-01 Primary completion 2015-09-01
Primary outcome
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
Study completed - no results published. This trial concluded in but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OCC Respiratory Virus Panel Nucleic Acid Assay System

All 42
Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K152386.
FilmArray Respiratory Panel EZ (RP EZ)
K152579 · Biofire Diagnostics, LLC · Oct 2016
Solana Influenza A+B Assay
K161814 · Quidel Corporation · Sep 2016
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
K160068 · Biofire Diagnostics, LLC · Feb 2016
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
K151226 · Cepheid · Dec 2015
ProFlu+ Assay
K153219 · Hologic, Inc. · Nov 2015
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
K143080 · Biofire Diagnostics, LLC · Feb 2015