(236 days)
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No
The summary describes a standard immunoturbidimetric assay for rheumatoid factor, with no mention of AI, ML, or related technologies.
No
The device is an in vitro diagnostic assay used for quantitative determination of human IgG rheumatoid factor antibodies, aiding in diagnosis of rheumatoid arthritis, not for therapy.
Yes
The "Intended Use / Indications for Use" section states: "The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA)." and "FOR IN VITRO DIAGNOSTIC USE."
No
The device is an in vitro diagnostic assay, which involves physical reagents and laboratory procedures, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The Intended Use section clearly states "FOR IN VITRO DIAGNOSTIC USE" for both the K-ASSAY® RF (Ver.2) assay and the K-ASSAY® RF Calibrator (Ver.2).
- Intended Use: The assay is designed for the "quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma," which are biological samples taken from the body.
- Diagnostic Purpose: The results are intended to be used "in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA)." This indicates a diagnostic purpose.
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA). FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.
Product codes
DHR
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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§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2020
Kamiya Biomedical Company Shawn Kaplan Clinical Diagnostics Product Manager 12779 Gateway Drive S Tukwila, Washington 98168
Re: K192727
Trade/Device Name: K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2) Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: Class II Product Code: DHR Dated: September 25, 2019 Received: April 17, 2020
Dear Shawn Kaplan:
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 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
1
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,
Carolina Kagan Acting Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192727
Device Name K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2)
Indications for Use (Describe)
The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA). FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.
| 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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