Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard molecular diagnostic techniques (PCR, hybridization, fluorescence intensity measurement) and software for analyzing MFI values, with no mention of AI or ML algorithms for data interpretation or diagnosis.

Therapeutic

No
This device is an in vitro diagnostic (IVD) test used for the detection and identification of pathogens, which aids in diagnosis. It does not provide treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device "aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings" for identifying microorganisms related to respiratory infections.

SaMD (Software as a Medical Device)

No

The device is a multiplexed PCR test that involves physical reagents, sample preparation, and analysis on a specific hardware instrument (Luminex MAGPIX). While it uses software for analysis, it is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is for the "simultaneous, qualitative detection of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (nasopharyngeal swab) outside of the body to aid in the diagnosis of a disease.
Device Description: The device description details the process of extracting nucleic acids from the sample, performing RT-PCR, and analyzing the results to identify specific pathogens. This entire process is performed in vitro (in a lab setting).
Clinical Study: The description of the clinical study further supports its IVD nature. The study evaluates the performance of the device in detecting pathogens in clinical specimens and compares the results to other diagnostic methods.
Predicate Device: The mention of a predicate device (BioFire Respiratory Panel 2.1) with a K number (DEN200031) indicates that this device is being compared to another legally marketed IVD device.

Therefore, based on the provided information, the NxTAG® Respiratory Pathogen Panel v2 clearly fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.

The following organism types and subtypes are identified and differentiated using the NxTAG RPPv2:

Viral Targets: Influenza A, Influenza A H1, Influenza A H1pdm09, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, SARS-CoV-2, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, Adenovirus, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4

Bacterial Targets: Chlamydia pneumoniae, Mycoplasma pneumoniae

Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in nasopharyngeal specimens during the acute phase of infection. The detection of specific viral and bacterial nucleic acids from individuals exhibiting signs and or symptoms of respiratory infection are indicative of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment management decisions.

Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by a nasopharyngeal swab specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the NxTAG RPP v2 may not be the definite cause of disease.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

The NxTAG® Respiratory Pathogen Panel v2 is indicated for use with the Luminex® MAGPIX® Instrument and xPONENT® and SYNCTTM software.

Product codes

OOF

Device Description

The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is designed to simultaneously detect and identify 21 different potential pathogens of respiratory tract infections, including the novel coronavirus SARS-CoV-2, from a single NPS specimen in transport medium. NxTAG® RPP v2 is compatible with Luminex's MAGPIX Instrument, and xPONENT® and SYNCT™ software. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) with the Luminex® proprietary universal tag sorting system on the Luminex platform to easily detect the 21 respiratory pathogen targets.

Samples are extracted using the IVD-labeled bioMérieux NucliSENS® easyMag® or EMAG® extraction systems. Extracted total nucleic acid is then added to the sealed 96-well micro plate by piercing the seal with pipette tips. Each reaction well is pre-plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, the reaction wells are re-sealed using the foils provided in the kit. The sealed plate can be placed inside the thermocycler. The reaction is amplified via RT-PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex® MAGPIX® instrument. The MAGPIX® instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population.

The signals are analyzed using the NxTAG® Respiratory Pathogen Panel v2 Assay File for SYNCT™ Software, providing a reliable, qualitative call for each of the 21 targets and internal controls within each reaction well.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasopharyngeal swab specimens

Indicated Patient Age Range

The study utilized leftover, de-identified specimens collected from pediatric and adult patients exhibiting clinical signs and symptoms of a respiratory tract infection.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A total of 1844 prospective specimens, collected from five geographically diverse US sites were initially enrolled in the study.
The clinical study utilized leftover, de-identified specimens collected from pediatric and adult patients exhibiting clinical signs and symptoms of a respiratory tract infection.
The NxTAG® RPP v2 results were compared to those obtained with an FDA-cleared molecular assay and PCR/bi-directional sequencing for influenza A subtyping. The twostep PCR analysis followed by BDS assays employed two independent sets of validated PCR assays. The primers used for PCR analysis and sequencing assays, where possible, were designed to amplify distinct regions from the investigational device. PCR analysis composite positive specimens were confirmed by BDS assays.
For targets that exhibited low prevalence rates in the prospective study cohort, the prospective specimen set was supplemented with 320 pre-selected left-over, deidentified specimens (Arm 2) sourced from six sites in the United States. Pre-selected specimens were identified by Standard of Care (SoC) results and confirmed by BDS testing prior to enrollment in the study. To minimize bias, pre-selected specimens were tested in a randomized, blinded manner with negative specimens at four sites.

Summary of Performance Studies

The performance of NxTAG® RPP v2 was assessed based on analytical performance and clinical performance.

Analytical Performance:

Precision (Reproducibility and Repeatability):
- Site-to-Site Reproducibility: A study was performed across 3 sites, with 2 operators at each site testing a 9-member reproducibility panel in 4 replicates on 5 non-consecutive days (total of 30 runs, 120 data points per sample member). Overall percent agreement was 99.90%.
- Lot-to-Lot Reproducibility: A study was performed at 1 site with 1 operator testing a 17-member reproducibility panel in 10 replicates on each of 3 assay kit lots (total of 30 data points per sample member). Overall percent agreement was 99.95%.
Detection Limit (LoD): LoD was assessed for each target by testing simulated samples prepared from high-titer cultured material or characterized clinical specimens. The LoD concentration for each target was defined as the lowest concentration at which ≥ 95% (≥ 19/20) of the replicates could be reproducibly detected.
Analytical Sensitivity for the First WHO International Standard for SARS-CoV-2: Evaluated at various concentrations (1/3x, 1x, 3x preliminary LoD). Determined as the lowest concentration at which ≥ 95% of replicates generated a positive call.
Analytical Reactivity (Inclusivity): Assessed by testing 193 pathogen strains/isolates (168 reactivity strains and 25 LoD strains) in triplicate. Successfully detected all but one Influenza A H1 strain (A/Denver/1/57 H1, subtype not detected) at tested concentrations. In silico analysis predicted ~99% inclusivity for Influenza A and B, and ≥96% for other targets (except Parainfluenza Virus 2 (~92%) and untyped Parainfluenza Virus 4 (~94%)).
Analytical Specificity (Exclusivity):
- Cross-Reactivity: Tested 63 organisms (82 strains total, 41 off-panel, 22 on-panel) in triplicate at high positive concentration. None showed cross-reactivity, except Enterovirus (Species D, Type 68, US/IL/14-18952) which generated a false positive for Influenza A H3 at ≥ 1.00E+03 TCID50/mL.
- In Silico Analysis: Predicted potential cross-reactivity of SARS-CoV-2 oligos with some SARS-related/bat coronaviruses, and Coronavirus 229E oligos with one bat 229E-like coronavirus sequence at high viral titer.
Microbial Interference: Evaluated 11 off-panel organisms against 22 on-panel organisms. No off-panel organism at high positive concentration interfered with the detection of any on-panel organism at low-moderate positive concentration.
Competitive Interference (Co-infection): Evaluated effect of high positive on-panel organisms on low-moderate positive on-panel organisms. No interference was detected. Additional testing for SARS-CoV-2 (low positive) against other high positive targets showed no interference.
Interfering Substances: Tested 20 non-microbial substances. Menthol interfered with Coronavirus OC43 at 1% w/v (no interference at 0.5% w/v). FluMist® generated expected positive calls for Influenza A, H1pdm09, H3, and B, as it contains attenuated strains.
Carry-Over/Cross-Contamination: Assessed for SARS-CoV-2 and Mycoplasma pneumoniae. Two false positives were observed for SARS-CoV-2 initially, but were resolved upon re-preparation and re-testing.

Comparison Studies:

Matrix and Multi-Analyte Sample Comparison: Demonstrated equivalency between multi-analyte (MA) and single target samples, and between NCM and negative simulated matrix (NSM). All targets in MA samples generated ≥ 95% positivity.
Specimen Collection Device Comparison: Nylon flocked tip and polyester tip swabs showed 100% positivity. Rayon-tipped swabs showed lower positivity (33% or 67% for certain targets), indicating they should not be used.
Specimen Collection Media and Extraction Comparison: Demonstrated equivalency between UTM and M4RT collection media, and between easyMAG and EMAG extraction systems, with ≥ 95% positivity for targets at ≤ 2x LoD.

Clinical Performance:

Study Design: Multi-site clinical study with prospective (Arm 1, n=1820 valid) and pre-selected (Arm 2, n=308 valid) de-identified nasopharyngeal swab specimens. Supplemented with contrived specimens (Arm 3, n=199 valid). Comparator methods included FDA-cleared molecular assays and PCR/bi-directional sequencing.
Key Results:
- Prospective Data Set (Table 19):
  - Adenovirus: PPA 95.9%, NPA 99.6%
  - Coronavirus 229E: PPA 100%, NPA 99.9%
  - Coronavirus HKU1: PPA 95.2%, NPA 100%
  - Coronavirus NL63: PPA 92.3%, NPA 100%
  - Coronavirus OC43: PPA 100%, NPA 100%
  - Human Metapneumovirus: PPA 100%, NPA 99.2%
  - Influenza A: PPA 100%, NPA 99.8%
  - Influenza A H1pdm09: PPA 100%, NPA 100%
  - Influenza A H1: PPA N/A (0/0 positives), NPA 100%
  - Influenza A H3: PPA 95.7%, NPA 99.9%
  - Influenza B: PPA 100%, NPA 100%
  - Parainfluenza 1: PPA 100%, NPA 100%
  - Parainfluenza 2: PPA 100%, NPA 100%
  - Parainfluenza 3: PPA 90%, NPA 100%
  - Parainfluenza 4: PPA 100%, NPA 99.9%
  - RSV A: PPA 86.7%, NPA 99.8%
  - RSV B: PPA 100%, NPA 99.8%
  - Rhinovirus / Enterovirus: PPA 100%, NPA 100%
  - SARS-CoV-2: PPA 95.1%, NPA 99.9%
  - Chlamydia pneumoniae: PPA N/A (0/0 positives), NPA 100%
  - Mycoplasma pneumoniae: PPA N/A (0/0 positives), NPA 100%
- Pre-Selected Data Set (Table 20): Generally high PPA and NPA (100% for many targets,
  - with a few in the 90s). Examples: Coronavirus HKU1 PPA 93.8%, Mycoplasma pneumoniae
  - PPA 92.3%.
- Contrived Data Set (Table 21): High PPA and NPA (mostly 100%, some in upper 90s). Examples:
  - RSV B PPA 98.0%, Chlamydia pneumoniae PPA 98.0%.

Conclusion: The study results demonstrate that the diagnostic accuracy of the NxTAG® RPP v2 assay is acceptable for the detections and identification of respiratory bacteria and viruses from NPS specimens collected from patients exhibiting clinical signs and symptoms of RTI.

Key Metrics

Clinical Performance - Prospective Data Set (Table 19):

Adenovirus: PPA 95.9% (94/98), NPA 99.6% (1709/1716)
Coronavirus 229E: PPA 100% (7/7), NPA 99.9% (1806/1807)
Coronavirus HKU1: PPA 95.2% (20/21), NPA 100% (1793/1793)
Coronavirus NL63: PPA 92.3% (48/52), NPA 100% (1762/1762)
Coronavirus OC43: PPA 100% (39/39), NPA 100% (1775/1775)
Human Metapneumovirus: PPA 100% (157/157), NPA 99.2% (1643/1657)
Influenza A: PPA 100% (74/74), NPA 99.8% (1737/1740)
Influenza A H1pdm09: PPA 100% (31/31), NPA 100% (1782/1782)
Influenza A H1: PPA N/A (0/0), NPA 100% (1813/1813)
Influenza A H3: PPA 95.7% (45/47), NPA 99.9% (1766/1767)
Influenza B: PPA 100% (11/11), NPA 100% (1803/1803)
Parainfluenza 1: PPA 100% (18/18), NPA 100% (1796/1796)
Parainfluenza 2: PPA 90% (9/10), NPA 100% (1804/1804)
Parainfluenza 3: PPA 100% (42/42), NPA 99.9% (1771/1772)
Parainfluenza 4: PPA 86.7% (13/15), NPA 99.8% (1796/1799)
RSV A: PPA 100% (55/55), NPA 99.8% (1756/1759)
RSV B: PPA 100% (20/20), NPA 100% (1794/1794)
Rhinovirus / Enterovirus: PPA 95.1% (351/369), NPA 99.9% (1444/1445)
SARS-CoV-2: PPA 97.9% (229/234), NPA 99.3% (1558/1569)
Chlamydia pneumoniae: PPA N/A (0/0), NPA 100% (1814/1814)
Mycoplasma pneumoniae: PPA N/A (0/0), NPA 100% (1814/1814)

Clinical Performance - Pre-Selected Data Set (Table 20):

Adenovirus: PPA 100% (1/1), NPA 100% (307/307)
Coronavirus 229E: PPA 100% (11/11), NPA 100% (297/297)
Coronavirus HKU1: PPA 93.8% (30/32), NPA 100% (276/276)
Coronavirus NL63: PPA N/A (0/0), NPA 100% (308/308)
Coronavirus OC43: PPA N/A (0/0), NPA 100% (308/308)
Human Metapneumovirus: PPA N/A (0/0), NPA 100% (308/308)
Influenza A: PPA 100% (30/30), NPA 99.6% (277/278)
Influenza A H1pdm09: PPA 96.7% (29/30), NPA 100% (278/278)
Influenza A H1: PPA N/A (0/0), NPA 99.6% (277/278)
Influenza A H3: PPA N/A (0/0), NPA 100% (278/278)
Influenza B: PPA 100% (30/30), NPA 100% (278/278)
Parainfluenza 1: PPA 100% (29/29), NPA 100% (279/279)
Parainfluenza 2: PPA 100% (30/30), NPA 100% (278/278)
Parainfluenza 3: PPA N/A (0/0), NPA 100% (307/307)
Parainfluenza 4: PPA 93.8% (15/16), NPA 100% (292/292)
RSV A: PPA N/A (0/0), NPA 99.3% (305/307)
RSV B: PPA N/A (0/0), NPA 99.7% (306/307)
Rhinovirus / Enterovirus: PPA 100% (1/1), NPA 98.7% (302/306)
SARS-CoV-2: PPA N/A (0/0), NPA N/A (0/0)
Chlamydia pneumoniae: PPA 100% (14/14), NPA 99.7% (293/294)
Mycoplasma pneumoniae: PPA 92.3% (48/52), NPA 100% (256/256)

Clinical Performance - Contrived Data Set (Table 21):

Coronavirus 229E: PPA 100% (49/49), NPA 100% (150/150)
Influenza A (matrix): PPA 100% (50/50), NPA 100% (149/149)
Influenza A H1 (subtype): PPA 100% (50/50), NPA 100% (149/149)
RSV B: PPA 98.0% (49/50), NPA 99.3% (148/149)
Chlamydia pneumoniae: PPA 98.0% (49/50), NPA 100% (149/149)

Predicate Device(s)

BioFire Respiratory Panel 2.1, DEN200031

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

(a)
Identification. A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (
e.g., BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (
e.g., when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
e.g., regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
e.g., saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads if infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to State or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
i.e., H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.

Summary

0

March 11, 2024

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Luminex Molecular Diagnostics, Inc. Kate Goscha Senior Manager, Regulatory Affairs 439 University Avenue Toronto, Ontario M5G 1Y8 Canada

Re: K231758

Trade/Device Name: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) Regulation Number: 21 CFR 866.3981 Regulation Name: Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The SARS-Cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-Target Test Regulatory Class: Class II Product Code: OOF Dated: June 15, 2023 Received: June 16, 2023

Dear Kate Goscha:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Joseph Briggs -S

Joseph Briggs Deputy Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231758

Device Name

NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2)

Indications for Use (Describe)