(384 days)
The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPLus turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings
Not Found
The provided document is a 510(k) clearance letter from the FDA for a diagnostic kit, specifically "Human Transferrin kit for use on the SPAPlus™". This type of document primarily confirms that a new device is substantially equivalent to a legally marketed predicate device, and it typically does not include detailed study reports with specific acceptance criteria, performance data, or details about training and test sets in the way that would be provided for an AI/ML medical device submission.
The information requested in the prompt (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is characteristic of the rigorous clinical validation studies required for AI/ML devices, not typically for a traditional in vitro diagnostic kit like the one described here.
Therefore, I cannot extract the requested information from the provided text because the document does not contain details about:
- A table of acceptance criteria and reported device performance in the context of an AI/ML device. The "performance" mentioned for this kit would usually refer to analytical performance characteristics (e.g., accuracy, precision, linearity) which are not detailed here.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance (as it's not an AI/ML algorithm).
- Type of ground truth used (beyond implying the "gold standard" for transferrin measurement).
- Sample size for training sets.
- How ground truth for training was established.
The document is a regulatory approval letter, specifically stating the device's substantial equivalence and its intended use for the quantitative determination of human transferrin to aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia using the Binding Site SPAPlus™ turbidimetric analyzer.
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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 consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
The Binding Site Group, Ltd. c/o Dr. Jill Constantine. Regulatory Affairs Scientist 8 Calthorpe Road Edgbaston, Birmingham West Midlands UK B15 IQT
February 13, 2013
· Re: K120236
Trade/Device Name: Human Transferrin kit for use on the SPAPlus™ Regulation Number: 21 CFR §866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDG Dated: February 11, 2013 Received: February 11, 2013
Dear Dr. Constantine:
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. Iisting 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 Part 801); medical device reporting (reporting of medical
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Page 2 - Dr. Jill Constantine
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria Mi &han -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology 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): K120236
Human Transferrin Kit for use on SPAPLus Device Name:
Indications For Use:
The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPLus turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings
Prescription Use
· AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
| Division Sign-Off | vonne Roose |
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Office of In Vitro Diagnostics and Radiological Health
| 510(k) | K120236 |
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§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).