NxTAG® Respiratory Pathogen Panel

K242613 · Luminex Molecular Diagnostics, Inc. · OCC · Oct 2, 2024 · Microbiology

Device Facts

• Record ID: K242613
• Device Name: NxTAG® Respiratory Pathogen Panel
• Applicant: Luminex Molecular Diagnostics, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Oct 2, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The NxTAG Respiratory Pathogen Panel is a multiplex nucleic acid assay intended for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms in nasopharyngeal swabs collected in universal transport media from individuals suspected of respiratory tract infections. The NxTAG Respiratory Pathogen Panel is intended to aid in the diagnosis of respiratory infections in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the panel. The agent detected may not be the definite cause of disease. Negative results do not preclude respiratory infection and should not be used as the sole basis for treatment or other patient management decisions.

Device Story

NxTAG Respiratory Pathogen Panel; multiplex nucleic acid assay; detects respiratory viral/bacterial pathogens in nasopharyngeal swabs. Modification adds limitation: hMPV positive results require confirmation by alternative molecular methods if medically indicated. Used in clinical laboratory settings by trained personnel. Output provides qualitative detection of specific pathogens to aid clinical diagnosis. Modification does not alter fundamental scientific technology.

Clinical Evidence

No clinical data provided; submission relies on design control activities, risk analysis, and verification/validation of labeling changes.

Technological Characteristics

Multiplex nucleic acid assay; utilizes molecular detection technology. Modification is limited to labeling (package insert) regarding hMPV result confirmation. No changes to physical or chemical characteristics.

Indications for Use

Indicated for symptomatic adult and pediatric patients (hospitalized, emergency department, or outpatient) with suspected respiratory tract infection to aid in the detection of specific viral and bacterial pathogens from nasopharyngeal swabs.

Regulatory Classification

Identification

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:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.

Special Controls

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K242613

B Applicant

Luminex Molecular Diagnostics, Inc.

C Proprietary and Established Names

NxTAG Respiratory Pathogen Panel

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OCC | Class II | 21 CFR 866.3980 - Respiratory Viral Panel Multiplex Nucleic Acid Assay | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was to add a limitation to the package insert stating that hMPV

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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positive results should be confirmed by alternative molecular methods if medically indicated.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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