(310 days)
The EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma (K3-EDTA, Li+heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.
Not Found
This FDA 510(k) clearance letter pertains to an In Vitro Diagnostic (IVD) device, specifically an ELISA test for autoantibodies. The provided text does not contain the kind of information typically associated with the development and validation of an AI/ML-based medical device, which would usually include details about:
- Algorithms and machine learning models
- Training and test datasets (sizes, provenance, ground truth establishment)
- Expert review processes (number of experts, qualifications, adjudication)
- MRMC studies or standalone AI performance metrics
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.
The document describes the regulatory clearance for the EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit, which is a laboratory assay.
Here's what can be extracted from the document:
- Device Name: EUROIMMUN Anti-BP230-CF ELISA (IgG)
- Regulation Number: 21 CFR 866.5660
- Regulation Name: Multiple autoantibodies immunological test system
- Regulatory Class: Class II
- Product Code: OEG
- Indications for Use: The test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.
To answer the detailed questions about acceptance criteria and study data for an AI/ML device, a different type of regulatory submission document (e.g., a summary of safety and effectiveness data or a clinical study report) would be required.
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September 17, 2020
EUROIMMUN US, Inc. Kruti Shah Regulatory Affairs Specialist 1 Bloomfield Avenue Mountain Lakes, New Jersey 07046
Re: K193115
Trade/Device Name: EUROIMMUN Anti-BP230-CF ELISA (IgG) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: OEG Dated: November 8, 2019 Received: November 12, 2019
Dear Kruti Shah:
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
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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 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 (QS) 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 medical devices and radiation-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,
Ying (Katelin) Mao, PhD Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193115
Device Name EUROIMMUN Anti-BP230-CF ELISA (IgG)
Indications for Use (Describe)
The EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma (K3-EDTA, Li+heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.
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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§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).