(108 days)
The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.
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The provided text is related to a 510(k) premarket notification for a medical device called the "RDI Ferritin Calibrator Set." This document is a letter from the FDA to the manufacturer, confirming substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a diagnostic or AI-based device.
The RDI Ferritin Calibrator Set is a calibrator, meaning it's used to establish a reference for quantitative measurements in a laboratory test (the RDI Ferritin Kit). Its performance is typically assessed by ensuring it produces consistent and accurate calibration curves, which in turn allows the associated assay (the RDI Ferritin Kit) to accurately measure ferritin levels.
Therefore, most of the questions you've asked, which are relevant to clinical studies validating the performance of a diagnostic or AI device (e.g., sample size for test sets, experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and are not present in this document.
However, I can extract the relevant information from the document:
1. A table of acceptance criteria and the reported device performance:
- Not applicable / Not provided in this document. This document is a regulatory approval letter, not a performance study report. The acceptance criteria for a calibrator would typically relate to its ability to accurately calibrate the assay it is designed for, ensuring linearity, precision, and stability. These specific criteria and their fulfillment are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided in this document. This document does not describe a clinical performance study using patient samples. Test sets as typically understood for diagnostic devices are not relevant here.
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):
- Not applicable / Not provided in this document. Ground truth, in the context of clinical device validation, refers to a definitive diagnosis or measurement. For a calibrator, "ground truth" would relate to the certified values of the calibrator itself, and its ability to correctly calibrate an assay, rather than a clinical expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided in this document.
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 / Not provided in this document. This is a calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided in this document. This is a physical calibrator set for an in vitro diagnostic assay, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided in this document. For a calibrator, the "ground truth" would be the assigned values of the calibrator materials themselves, which are established through a rigorous manufacturing and testing process to ensure accuracy and traceability to reference methods. This information is not in the FDA letter.
8. The sample size for the training set:
- Not applicable / Not provided in this document. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided in this document.
Summary of what is in the document:
- Device Name: RDI Ferritin Calibrator Set
- Intended Use: To establish points of reference for the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, for use with the RDI Ferritin Kit.
- Regulatory Status: Class II device, found substantially equivalent to legally marketed predicate devices.
- Product Code: JIT
- Approval Date: March 13, 2006
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administrat 2098 Gaither Road Rockville MD 20850
MAR 1 3 2006
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford MA, 01730
Re: K053291 Trade/Device Name: RDI Ferritin Calibrator Set Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: February 23, 2006 Received: February 24, 2006
Dear Dr. Lawlor:
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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053291
Device Name:
RDI Ferritin Calibrator Set
Indications For Usc:
The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CA
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
10(k) KOS3291
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.