(84 days)
The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm loss of antigen be done at least four weeks following completion of therapy.
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The provided document is a 510(k) premarket notification letter for the ImmunoCard STAT! HpSA device. It primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance information, rather than a detailed study report with acceptance criteria and performance data.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document does not contain the specific details of a study, acceptance criteria, or performance metrics. It's a regulatory approval letter.
However, I can extract information related to the device and the type of data that would be relevant if a full study report were available.
Based on the provided document, here's what I can infer and what is missing:
The device, ImmunoCard STAT! HpSA, is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori (H. pylori) antigens in human stool. It is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment.
To address your request, if a full study report were available, it would typically include the following information:
1. A table of acceptance criteria and the reported device performance
- Missing from the document. A study report would typically define performance metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) or overall agreement, along with the pre-defined target values (acceptance criteria).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing from the document. A study report would specify the number of patient samples included in the test set, whether the samples were collected prospectively or retrospectively, and details about the patient population and geographical origin.
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)
- Missing from the document. For a diagnostic test like this, the "ground truth" would likely be established using a comparator method (e.g., culture, biopsy with histological examination, UBT, or another validated molecular test). The experts involved would typically be clinical microbiologists, gastroenterologists, or pathologists. The number and qualifications would depend on the complexity of the ground truth method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable in the context of this device. Adjudication methods like "2+1" (where two readers agree, or a third reader resolves discrepancies) are common in imaging studies. For a qualitative diagnostic test like the ImmunoCard STAT! HpSA, adjudication typically refers to the resolution of discrepancies between the device's result and the reference standard, rather than between multiple human readers interpreting the device's output.
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
- Not applicable. The ImmunoCard STAT! HpSA is a qualitative in vitro diagnostic device, not an AI-based imaging interpretation system. Therefore, MRMC studies involving human readers improving with AI assistance are not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Could be considered "standalone" in a different sense. The ImmunoCard STAT! HpSA provides a direct qualitative result (positive/negative) based on antigen detection. Its performance is evaluated as the device itself, without a "human-in-the-loop" in the same way an AI algorithm for image analysis would be. A standalone study for this device would assess its accuracy against a known truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred based on "H. pylori antigen detection": For H. pylori detection, the gold standard (ground truth) typically used in clinical studies includes:
- Culture: Growing the bacteria from biopsy samples.
- Histology: Microscopic examination of gastric biopsy tissues for H. pylori.
- Urea Breath Test (UBT) or Stool Antigen Test (SAT) using a highly sensitive and specific comparator method: These are non-invasive methods, often used as reference for other non-invasive tests.
- Rapid Urease Test (RUT): Performed on biopsy samples.
- Overall Clinical Diagnosis: Based on a combination of invasive and non-invasive tests.
- The specific ground truth used for ImmunoCard STAT! HpSA would be detailed in a study report.
8. The sample size for the training set
- Not applicable in the context of this device. The ImmunoCard STAT! HpSA is a biochemical/immunological test kit, not an AI or machine learning algorithm that requires a "training set." Its design and optimization would involve R&D and validation, but not in the sense of AI model training.
9. How the ground truth for the training set was established
- Not applicable. As above, training sets and their ground truth establishment are relevant for AI/ML models, not for this type of in vitro diagnostic kit.
In summary: The provided document is a regulatory communication of FDA clearance. To answer your detailed questions about acceptance criteria and study particulars, a separate clinical study report or performance evaluation data would be required.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
MERIDIAN BIOSCIENCE, INC SUSAN ROLIH EVP, REGULATORY AND QUALITY SYSTEMS 3471 RIVER HILLS DRIVE CINCINNATI OH 45244
Re: K153661
Trade/Device Name: ImmunoCard STAT! HpSA Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: LYR Dated: December 18, 2015 Received: December 21, 2015
Dear Ms. Rolih:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S
For Uwe Scherf, M.Sc., Ph.D. 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) K153661
Device Name
ImmunoCard STAT! HpSA
Indications for Use (Describe)
The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm loss of antigen be done at least four weeks following completion of therapy.
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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§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).