(117 days)
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No
The summary describes a standard in vitro diagnostic kit for measuring ferritin using immunoturbidimetric methods, with no mention of AI or ML.
No.
The document explicitly states "For in vitro diagnostic use only" and describes a kit for the quantitative determination of Ferritin in serum or plasma, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." It also describes the kit's purpose in determining ferritin levels, which are useful in assessing iron stores and evaluating conditions like iron deficiency anemia and hemochromatosis, all of which are diagnostic applications.
No
The device is an in vitro diagnostic kit for measuring Ferritin, which implies it includes reagents and potentially hardware components for the immunoturbidimetric measurement, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the primary indicator that the device is intended for use outside of the body to examine specimens from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
The description of what the kit measures (Ferritin in human serum or plasma) and the clinical utility (assessing iron stores, evaluating iron deficiency anemia and hemochromatosis) further confirms its role as an IVD.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.
Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.
Product codes
DBF
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
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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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§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).
0
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 features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
MAR 1 3 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford, Massachusetts 01730
Re: K053211
Trade/Device Name: RDI Ferritin Kit Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF 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). 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.
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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,
lobatz Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment B.
Indications for Use
510(k) Number (if known): K053211
Device Name: RDI Ferritin Kit
Indications For Use:
For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.
Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.
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)
J. Rlove for m. Chen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Sailty
KO52211 . 510(k)_
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