Search Results

NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The test is indicated as an aid in the detection of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatic patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection.

Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorties, specimens should be collected with appropriate infections 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.

NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The information provided does not contain details about specific acceptance criteria or a study proving the device meets those criteria. The document is an FDA clearance letter for the NxTAG Respiratory Pathogen Panel, indicating that the device has been substantially equivalenced to a predicate device for its stated indications for use.

While the "Indications for Use" section (Page 3) describes the intended use of the device and some general performance characteristics for influenza A, it does not present a table of acceptance criteria or detailed study results. It mentions that performance characteristics for influenza A were established using specimens from specific influenza seasons, but it doesn't quantify those characteristics or define specific thresholds for acceptance.

Therefore, I cannot fulfill your request for the detailed table, sample sizes, expert information, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based on the provided text. This document is a regulatory clearance, not a performance study report.

Ask a specific question about this device

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.

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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Luminex NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2):

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 from individuals with signs and symptoms of respiratory tract infection, including COVID-19.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NxTAG® RPP v2 assay are implied through the robust analytical and clinical performance studies, specifically focusing on sensitivity (Limit of Detection, LoD, and Positive Percent Agreement, PPA) and specificity (Analytical Specificity, Cross-Reactivity, and Negative Percent Agreement, NPA), as well as reproducibility and stability.

Here's a summary of the performance as reported in the document:

Table 1: Acceptance Criteria and Reported Device Performance (Key Metrics)

Study to Prove Device Meets Acceptance Criteria

The device's performance was evaluated through a combination of analytical and clinical studies.

1. Sample sizes used for the test set and data provenance:

   • Analytical Studies (Reproducibility):
     • Site-to-Site: 9-member reproducibility panel tested in 4 replicates on 5 non-consecutive days by 2 operators at 3 sites (30 runs x 4 replicates = 120 data points per panel member). Total of 22,560 data points.
     • Lot-to-Lot: 17-member reproducibility panel tested in 10 replicates on each of 3 assay kit lots by 1 operator at 1 site (30 data points per panel member). Total of 10,680 data points.
     • LoD: 20 replicates for each target.
     • Analytical Reactivity/Specificity/Interference: Generally, 3 replicates per strain/substance.
   • Clinical Studies (Test Set):
     • Prospective (Arm 1): 1820 prospectively collected de-identified specimens (after retest resolving invalid results). Data provenance: Five geographically diverse clinical sites within the United States. Type: Prospective.
     • Pre-selected (Arm 2): 308 pre-selected, de-identified leftover specimens (after retest resolving invalid results). Data provenance: Six sites in the United States. Type: Retrospective (leftover specimens).
     • Contrived (Arm 3): 199 contrived specimens (spiked into negative human nasopharyngeal specimens). Type: Laboratory-generated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts involved in establishing the ground truth.
   • For the clinical study, the ground truth was established by:
     • An FDA-cleared molecular assay (predicate device or other cleared assays).
     • PCR followed by bi-directional sequencing (BDS) for specific targets (Influenza A subtyping, and to confirm pre-selected specimens and indeterminate results from the molecular comparator).
   • The implication is that these are either validated laboratory methods or the expertise is inherent in the design and validation of the comparator FDA-cleared molecular assay. For PCR/BDS, it would typically be performed by trained molecular diagnosticians or laboratory personnel.

3. Adjudication method for the test set:

   • The document describes a comparator method algorithm: The NxTAG® RPP v2 results were compared to an FDA-cleared molecular assay. For influenza A subtyping, and potentially for other targets where initial molecular testing was insufficient, PCR/bi-directional sequencing (BDS) was used.
   • Composite reference method: For cases where the initial FDA-cleared molecular assay provided certain results (e.g., in some cases of false positives/negatives for Adenovirus, Human Metapneumovirus, Influenza A, RSV A, and SARS-CoV-2 in the prospective cohort, as noted in the footnotes to Table 19), further investigation with molecular SoC assay or BDS was conducted to determine the final truth. This represents a form of adjudication, where a "truth" panel (FDA-cleared assay + PCR/BDS) is used to establish the final ground truth.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This question is not applicable to this device. The NxTAG® RPP v2 is an in vitro diagnostic (IVD) PCR test kit for detecting nucleic acids, not an AI-assisted diagnostic imaging or human-in-the-loop (HITL) system. The output is qualitative (positive/negative for each pathogen), and does not involve human "readers" in the context of image interpretation that would be augmented by AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not entirely applicable in the AI sense, as it’s a molecular diagnostic test. However, the analytical performance studies (e.g., LoD, inclusivity, exclusivity, precision) can be considered "standalone" performance of the assay itself, demonstrating its inherent accuracy in detecting specific pathogens under controlled conditions, without the variability of actual clinical human samples that might contain inhibitors or mixed infections. The outputs are generated by the Luminex® MAGPIX® Instrument and xPONENT® and SYNCT™ software, which provides a "reliable, qualitative call for each of the 21 targets and internal controls." This part of the system operates without continuous human "in-the-loop" interpretation of the raw data for diagnosis on a case-by-case basis.

6. The type of ground truth used:

   • Clinical Study:
     • Reference molecular methods: An FDA-cleared molecular assay was the primary comparator.
     • Confirmatory sequencing: PCR followed by bi-directional sequencing (BDS) was used for specific targets (e.g., influenza A subtyping) and to confirm pre-selected specimens prior to enrollment, and potentially to adjudicate discrepancies.
   • Analytical Studies:
     • Known concentrations: For LoD and analytical reactivity/specificity, samples were prepared with known concentrations of highly characterized viral or bacterial strains (cultured material, clinical specimens of known titer, or WHO standards).
     • In silico analysis: For inclusivity and exclusivity, genetic sequences from public databases (GISAID EpiCoV, GISAID EpiFlu, GenBank) were analyzed, assuming complete detection if probe binding matched certain criteria.

7. The sample size for the training set:

   • The document describes a marketing submission (510(k)) for a medical device that has completed its development and validation. Therefore, it focuses on the test set (clinical validation and analytical verification) rather than a "training set" which is typically associated with machine learning model development. For an IVD such as this, the "training" (i.e., development and optimization) of the assay's reagents and parameters would have occurred internally during product development, using various internal samples and iterative refinement. The document does not specify the sample size of any development/training set.

8. How the ground truth for the training set was established:

   • As noted above, a "training set" in the context of this 510(k) submission would refer to the internal development and optimization work, not typically disclosed in detail for regulatory submissions like this. The ground truth during that phase would have been established through a combination of purified nucleic acid standards, well-characterized clinical samples, and comparison to established reference methods or culture, depending on the stage of development.

Ask a specific question about this device

NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatic patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection.

Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorties, 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.

Not Found

The provided document is an FDA 510(k) clearance letter for the NxTAG Respiratory Pathogen Panel, a diagnostic device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way described in your prompt (e.g., performance against ground truth established by experts, MRMC studies, or standalone algorithm performance). This document is primarily an administrative letter confirming substantial equivalence to a predicate device and outlining regulatory information.

The information you are requesting typically comes from detailed study reports submitted as part of the 510(k) application, which are not included in this clearance letter. The letter briefly mentions "Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons," but it does not provide the specific performance metrics, study design, or ground truth details.

Therefore, I cannot fulfill your request using only the information provided in the given document. The document confirms the device's clearance and its intended use, but it does not delve into the specifics of the validation study's acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

Not Found

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the xTAG Gastrointestinal Pathogen Panel (GPP) does not contain the specific information required to answer your questions about acceptance criteria and the detailed study that proves the device meets those criteria.

The letter primarily confirms the substantial equivalence of the device to a predicate device and outlines regulatory requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size used for a test set, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Details regarding the training set's sample size or ground truth establishment.

To obtain this information, you would typically need to refer to the 510(k) summary document or the full 510(k) submission (if publicly available), which often contain the study design and results for substantial equivalence demonstrations. The letter itself is a notice of clearance, not a comprehensive study report.

Ask a specific question about this device

The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes, and toxin genes are identified using the xTAG GPP: Viruses •Adenovirus 40/41 •Norovirus GI/GII •Rotavirus A Bacteria ·Campylobacter (C. jejuni, C. coli, and C. lari only) ·Clostridium difficile (C. difficile) toxin A/B •Escherichia coli (E. coli) O157 · Enterotoxigenic E. coli (ETEC) LT/ST •Salmonella •Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 ·Shigella (S. boydii, S. sonnei, S. flexneri, and S. dysenteriae) · Vibrio cholerae (V. cholerae) cholera toxin gene (ctx) Parasites •Cryptosporidium (C. parvum and C. hominis only) ·Entamoeba histolytica (E. histolytica) · Giardia (G. lamblia only, also known as G. intestinalis and G. duodenalis) The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestion when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection of acute gastroenteritis in the context of outbreaks. xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG GPP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. xTAG GPP is not intended to monitor or guide treatment for C. difficile infections. The xTAG GPP test is indicated for use with the Luminex 100/200™ and MAGPIX instruments with xPONENT software.

The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes, and toxin genes are identified using the xTAG GPP: Viruses •Adenovirus 40/41 •Norovirus GI/GII •Rotavirus A Bacteria ·Campylobacter (C. jejuni, C. coli, and C. lari only) ·Clostridium difficile (C. difficile) toxin A/B •Escherichia coli (E. coli) O157 · Enterotoxigenic E. coli (ETEC) LT/ST •Salmonella •Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 ·Shigella (S. boydii, S. sonnei, S. flexneri, and S. dysenteriae) · Vibrio cholerae (V. cholerae) cholera toxin gene (ctx) Parasites •Cryptosporidium (C. parvum and C. hominis only) ·Entamoeba histolytica (E. histolytica) · Giardia (G. lamblia only, also known as G. intestinalis and G. duodenalis) The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestion when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection of acute gastroenteritis in the context of outbreaks. xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG GPP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. xTAG GPP is not intended to monitor or guide treatment for C. difficile infections. The xTAG GPP test is indicated for use with the Luminex 100/200™ and MAGPIX instruments with xPONENT software.

The provided document does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter for the xTAG Gastrointestinal Pathogen Panel (GPP), outlining its indications for use and regulatory information. It does not detail the specific performance study results, acceptance criteria, or the methodology of such a study.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes and toxin genes are identified using the xTAG GPP:

Viruses

• · Adenovirus 40/41
• · Norovirus GI/GII
• · Rotavirus A

Bacteria

• · Campylobacter (C. jejuni, C. coli and C. lari only)
• · Clostridium difficile (C. difficile) toxin A/B
• · Escherichia coli (E. coli) O157
• · Enterotoxigenic E. coli (ETEC) LT/ST
• · Salmonella
• · Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2
• · Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae)
• · Vibrio cholerae (V. cholerae) cholera toxin gene (ctx)

Parasites

• · Cryptosporidium (C. parvum and C. hominis only)
• · Entamoeba histolytica (E. histolytica)
• · Giardia (G. lamblia only, also known as G. intestinalis and G. duodenalis)

The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestion when used in conjunction with clinical evaluation, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection of acute gastroenteritis in the context of outbreaks.

xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG GPP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

xTAG GPP is not intended to monitor or guide treatment for C. difficile infections.

The xTAG GPP test is indicated for use with the Luminex® 100/200™ and MAGPIX® instruments with xPONENT® software.

Not Found

The provided text is a 510(k) clearance letter for the xTAG Gastrointestinal Pathogen Panel (GPP) and xTAG Data Analysis Software (TDAS GPP). While it details the "Indications for Use" and general regulatory information, it does not contain the specific technical acceptance criteria, study details, or performance data for the device.

Therefore, I cannot provide the requested information based on the given input.

To answer your request, I would need a section of the document that describes the clinical performance study, often found in a "Performance Data" or "Clinical Study Results" section of a 510(k) submission. This section typically includes:

• Acceptance Criteria: Predetermined performance targets (e.g., sensitivity, specificity, positive predictive agreement, negative predictive agreement thresholds).
• Reported Device Performance: The actual sensitivity, specificity, and other metrics achieved by the device in the study.
• Study Design: Details about the sample size, data provenance, ground truth establishment, and any comparison to predicate devices or reference methods.

Without this information in the provided text, I am unable to populate the table or answer the specific questions about the study design.

Ask a specific question about this device

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes and toxin genes are identified using the xTAG GPP:

Viruses

• · Adenovirus 40/41
• · Norovirus GI/GII
• · Rotavirus A

Bacteria

• · Campylobacter (C. jejuni, C. coli and C. lari only)
• · Clostridium difficile (C. difficile) toxin A/B
• · Escherichia coli (E. coli) O157
• · Enterotoxigenic E. coli (ETEC) LT/ST
• · Salmonella
• · Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2
• · Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae)
• · Vibrio cholerae (V. cholerae) cholera toxin gene (ctx)

Parasites

• · Cryptosporidium (C. parvum and C. hominis only)
• · Entamoeba histolytica (E. histolytica)
• · Giardia (G. lamblia only, also known as G. intestinalis and G. duodenalis)

The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestion when used in conjunction with clinical evaluation, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection of acute gastroenteritis in the context of outbreaks.

xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG GPP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

xTAG GPP is not intended to monitor or guide treatment for C. difficile infections.

The xTAG GPP test is indicated for use with the Luminex® 100/200™ and MAGPIX® instruments with xPONENT® software.

Not Found

The provided text is a 510(k) premarket notification for the xTAG Gastrointestinal Pathogen Panel (GPP) and xTAG Data Analysis Software (TDAS GPP). It outlines the device's intended use and the FDA's decision regarding its substantial equivalence. However, it does not contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for the performance of the device itself.

The document mainly focuses on:

• Regulatory information: Device name, regulation number, regulatory class, product code, and the FDA's decision of substantial equivalence.
• Indications for Use: A detailed description of the pathogens the xTAG GPP can detect, from what sample type, and for what purpose (diagnosis of gastrointestinal infection, aid in outbreak detection). It also includes important disclaimers about the presumptive nature of positive results, the need for confirmation, and limitations of the test.
• Intended Use Environment: Specifies the instruments the test is indicated for use with.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the full 510(k) submission which would detail the validation studies.

Ask a specific question about this device

Not Found

Not Found

The provided document is an FDA 510(k) clearance letter for a medical device called "xTAG CYP2D6 Kit V3". This type of document does not contain the detailed technical information about acceptance criteria, study methodologies, or performance data that would be necessary to answer your request.

The letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It informs the manufacturer about regulatory obligations but does not include the specifics of the performance studies.

To get the information you are looking for (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.), you would typically need to refer to documents like:

• The 510(k) summary or 510(k) Traditional submission itself, which is often publicly available through the FDA's database.
• The device's Instruction for Use (IFU) or Product Insert, which usually contains performance data.
• Scientific publications if the study results were published in peer-reviewed journals.

Therefore, based solely on the provided document, I cannot fulfill your request for: a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details.

Ask a specific question about this device

The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transment conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. The xTAG Cystic Fibrosis 60 Kit v2 is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

Not Found

The provided text is a 510(k) premarket notification letter for the Luminex Molecular Diagnostics xTAG® Cystic Fibrosis 60 Kit v2. This document is a regulatory approval letter and does not contain the detailed study information typically found in a clinical trial report or a scientific publication. Therefore, I cannot provide all the requested information.

However, based on the nature of the device (a molecular diagnostic kit for detecting genetic mutations), I can infer some aspects and explicitly state what is not present in the document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device but does not typically detail the specific performance metrics (like sensitivity, specificity, accuracy) or the pre-defined acceptance criteria from the validation studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The letter does not describe the specific studies conducted, including sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. For genetic testing, ground truth would typically be established by Sanger sequencing or another highly accurate molecular method, not by human experts in the way that imaging studies use radiologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document. Adjudication methods are typically relevant for subjective assessments, which is not the primary mode of operation for a genetic diagnostic kit.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not available in the provided document. This device is a genetic testing kit, not an AI-assisted diagnostic tool that involves human readers interpreting images or other data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is partially applicable but not detailed in the provided document. The xTAG® Cystic Fibrosis 60 Kit v2 is a qualitative genotyping test. This implies it operates in a "standalone" fashion in terms of detecting mutations, producing results without human interpretive input beyond running the assay and reading the output. However, the letter does not provide details of such a "standalone performance" study or its results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a genetic testing kit, the ground truth would typically be established by a gold standard molecular method, such as:

• Sanger Sequencing: Considered the gold standard for definitive mutation identification.
• Next-Generation Sequencing (NGS): Can also be used to confirm mutations.
• Reference materials with known genotypes: Commercially available or laboratory-validated samples with confirmed mutation status.

However, the specific method used for establishing ground truth for the xTAG® Cystic Fibrosis 60 Kit v2 is not detailed in this document.

8. The sample size for the training set

This information is not available in the provided document. This type of device does not typically have a "training set" in the machine learning sense. Instead, assay development involves extensive analytical validation and clinical validation studies.

9. How the ground truth for the training set was established

This information is not applicable and not available in the provided document. As mentioned, this is not an AI/machine learning device with a training set.

Ask a specific question about this device

The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. The xTAG Cystic Fibrosis 39 Kit v2 is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

Not Found

The provided text is a cover letter from the FDA to Luminex Molecular Diagnostics, Inc. regarding their xTAG™ Cystic Fibrosis 39 Kit v2. While it confirms the device's substantial equivalence and lists its indications for use, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

The document states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the study data was submitted to the FDA as part of the 510(k) premarket notification, but this specific document does not provide the study details.

Therefore, I cannot provide the requested information based on the text provided. To answer your questions, details from the actual 510(k) submission or subsequent study publications would be needed.

Ask a specific question about this device