(29 days)
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.
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).