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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.

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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