(187 days)
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No
The summary describes a multiplexed nucleic acid test for pathogen detection, which is a standard molecular diagnostic technique. There is no mention of AI or ML in the intended use, device description, or any other section. The technology described is based on identifying specific nucleic acid sequences.
No.
The device is a diagnostic test intended for the qualitative detection and identification of multiple viral, bacterial, and parasitic nucleic acids in human stool specimens, aiding in the diagnosis of gastrointestinal infections. It does not provide treatment or directly manage patient conditions, therefore it is not a therapeutic device.
Yes
The text states that the device "aids in the diagnosis of gastrointestion when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information." This directly indicates its role as a diagnostic tool.
No
The device description explicitly states that the xTAG GPP test is indicated for use with the Luminex 100/200™ and MAGPIX instruments, which are hardware components. The device is a test kit that utilizes these instruments, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device 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..." This describes a test performed in vitro (outside the body) on a biological sample (stool) to provide diagnostic information.
- Purpose: The test "aids in the diagnosis of gastrointestion when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information." This clearly indicates a diagnostic purpose.
- Sample Type: The test is performed on "human stool specimens or human stool in Cary-Blair media," which are biological samples.
The description aligns perfectly with the definition 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, 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.
Product codes
PCH
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
Stool specimens
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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November 4, 2019
Luminex Molecular Diagnostics, Inc. Tina Ip Senior Regulatory Affairs Associate 439 University Avenue Toronto, M5g 1y8 Ca
Re: K191160
Trade/Device Name: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay Regulatory Class: Class II Product Code: PCH Dated: April 23, 2019 Received: May 1, 2019
Dear Tina Ip:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Kristian Roth, Ph.D. Branch Chief Bacterial Multiplex and Medical Countermeasures Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191160
Device Name
xTAG Gastrointestinal Pathogen Panel (GPP)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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