(236 days)
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.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2)". This device is an in-vitro diagnostic test for quantitative determination of human IgG rheumatoid factor antibodies.
The letter explicitly states that the device is a "Rheumatoid Factor Immunological Test System" (Regulation Name: 21 CFR 866.5775) and is a "Class II" device.
Crucially, this document is an FDA clearance letter for a laboratory test (an in-vitro diagnostic device), not an AI/ML-based medical device that would have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC, or involve human readers and their improvement with AI assistance.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML, human readers, ground truth establishment, etc., is not applicable to this type of device and will not be found in this document.
The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device, and performance measures like precision, accuracy, linearity, measuring range, interference, and agreement studies for clinical performance. These are standard validation tests for IVD products, not AI performance metrics.
In summary, based on the provided text, I cannot provide the requested information because it pertains to an AI/ML medical device, which the K-ASSAY® RF (Ver.2) is not.
I can, however, extract the following relevant information from the document as it pertains to a medical device:
- 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
- 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 rheumatoid 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: Prescription Use
- Predicate Device: The letter states the device is "substantially equivalent" to legally marketed predicate devices, but the specific predicate device is not named in this letter.
To reiterate, the questions about acceptance criteria, study design, sample sizes, experts, ground truth, MRMC studies, standalone performance, and training sets are not applicable to this medical device submission as described in the provided FDA 510(k) clearance letter.
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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
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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
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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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§ 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).