(265 days)
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No
The description focuses on a multiplexed nucleic acid test for pathogen detection and identification, with no mention of AI or ML in the intended use, device description, or other sections.
No
Explanation: This device is a diagnostic test designed for the detection and identification of pathogens, not for treating or preventing disease.
Yes
The text explicitly states that the device is "intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens" and "aids in the diagnosis of gastrointestinal infection".
No
The device is a multiplexed nucleic acid test that analyzes stool specimens using a specific instrument (Luminex® MAGPIX®). This involves physical reagents, laboratory procedures, and hardware, making it a hardware-based diagnostic test, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test is for the "simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (stool) outside of the body to aid in the diagnosis of a disease.
- Sample Type: The test uses "human stool specimens," which are biological samples collected from a patient.
- Purpose: The purpose is to "aid in the diagnosis of gastrointestinal infection" and "aid in the detection and identification of acute gastroenteritis in the context of outbreaks." This directly aligns with the definition of an IVD, which is used to diagnose or detect diseases or conditions.
- Clinical Context: The intended use mentions using the results "in conjunction with clinical evaluation, laboratory findings and epidemiological information," further indicating its role in a clinical diagnostic process.
The fact that it's a "multiplexed nucleic acid test" and uses a specific instrument (Luminex® MAGPIX®) are details about the technology used, but the core function and intended use clearly place it within the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens 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:
- Campylobacter (C. jejuni, C. coli and C. lari only) .
- Clostridium difficile (C. difficile) toxin A/B ●
- Cryptosporidium (C. parvum and C. hominis only) ●
- Escherichia coli (E. coli) 0157 .
- Enterotoxigenic Escherichia coli (ETEC) LT/ST ●
- Giardia (G. lamblia only also known as G. intestinalis and G. duodenalis)
- . Norovirus GI/GII
- . Rotavirus A
- Salmonella ●
- Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 .
- Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) ●
The detection and identification of 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, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
xTAG® GPP positive results are presumptive and must be confirmed by FDAcleared 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 coinfection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG® Gastrointestinal Pathogen Panel 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 is indicated for use with the Luminex® MAGPIX® instrument.
Product codes (comma separated list FDA assigned to the subject device)
PCH, NSU, JJH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
March 21, 2013
Luminex Molecular Diagnostics, Inc. Lubna Syed Director, Regulatory Affairs 439 University Ave., Suite 900 Toronto, Canada M5G 1Y8
Re: K121894
Trade/Device Name: xTAG® Gastrointestinal Pathogen Panel (GPP) Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal microorganism multiplex nucleic acid-based assay Regulatory Class: Class II Product Code: PCH, NSU, JJH Dated: January 25, 2013 Received: January 28, 2013
Dear Ms. Syed:
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 (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. 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.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Lubna Syed
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally Aೃଖି djyat
Sally Hojvat Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121894
121894
Device Name: xTAG® Gastrointestinal Pathogen Panel (GPP)
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens 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:
- Campylobacter (C. jejuni, C. coli and C. lari only) .
- Clostridium difficile (C. difficile) toxin A/B ●
- Cryptosporidium (C. parvum and C. hominis only) ●
- Escherichia coli (E. coli) 0157 .
- Enterotoxigenic Escherichia coli (ETEC) LT/ST ●
- Giardia (G. lamblia only also known as G. intestinalis and G. duodenalis)
- . Norovirus GI/GII
- . Rotavirus A
- Salmonella ●
- Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 .
- Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) ●
The detection and identification of 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, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
xTAG® GPP positive results are presumptive and must be confirmed by FDAcleared 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 coinfection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG® Gastrointestinal Pathogen Panel 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 is indicated for use with the Luminex® MAGPIX® instrument.
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Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
John Hoppsons -09:51 -04'00'