(253 days)
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No
The summary describes a standard immunoturbidimetric assay for measuring ferritin, which is a chemical reaction-based method and does not involve AI or ML. There are no mentions of AI, ML, image processing, or data analysis techniques typically associated with AI/ML.
No
This device is an in vitro diagnostic reagent used for the quantitative determination of ferritin, which aids in the diagnosis of diseases. It does not directly treat or alleviate a disease, but rather provides information for diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay aids "in the diagnosis of diseases affecting iron overload and iron deficiency anemia."
No
The device is an in vitro diagnostic reagent (assay and calibrator set) used on a specific analyzer, which are physical components, not software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent..."
- "For in vitro diagnostic use."
- "The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent..."
- "For in vitro diagnostic use."
These statements clearly indicate that the device is intended for use in examining specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay.
For in vitro diagnostic use.
Product codes
DBF, JIT
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Kamiva Biochemical Company c/o Mr. Brian Schliesman Director 12779 Gateway Dr. Seattle, WA 98168
DEC 2 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K050944
Trade/Device Name: K-Assay® Ferritin (2) and K-Assay® Ferritin Calibrator Set Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, JIT Dated: April 6, 2005 Received: April 21, 2005
Dear Mr. Schliesman:
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 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 Parl 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Robert Beckerh
Robert L. Becker, Jr., MD, PH.D 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO50944 4
K-ASSAY® Ferritin (2) and K-ASSAY® Ferritin Calibrator Set Device Name:
Indications For Use:
The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay.
For in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
maria r for Concurrence of CD Miston State Evaluation (ODE)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050944
Prescription Use × (Per 21 CFR 801.109) Over-The-Counter Use
Optional Format 1-2-96)
4/06/2005
Ferritin (2) 510(k) KAMIYA BIOMEDICAL COMPANY OR