(48 days)
The K-ASSAY Rheumatoid Factor is intended to be used for the quantitative determination of human rheumatoid factor in human serum by immunoturbidimetric assay.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "K-ASSAY Rheumatoid Factor." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving device performance in the manner requested.
The FDA 510(k) process primarily evaluates a new device's "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as an already legally marketed device. It does not typically require the submission of detailed clinical trials with specific acceptance criteria and outcome measures as one might find in a Premarket Approval (PMA) application or a comprehensive scientific publication.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the document:
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A table of acceptance criteria and the reported device performance: This information is not present in the document. The letter states the device is "substantially equivalent" to predicate devices, but it does not provide specific performance metrics or acceptance criteria used in the equivalence determination.
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Sample size used for the test set and the data provenance: This information is not present. The type of study (if any, beyond equivalency testing) and details about the test set (sample size, origin, retrospective/prospective) are not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. Ground truth establishment details are not part of this regulatory letter.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
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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: This information is not applicable or present. The device is an in vitro diagnostic (IVD) for quantitative determination of rheumatoid factor, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device appears to be a standalone in vitro diagnostic assay for laboratory use, but the details of its "standalone" performance (e.g., sensitivity, specificity, accuracy) are not provided in this regulatory letter. The performance data would have been part of the 510(k) submission, but is not detailed here.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present. For IVDs, ground truth typically involves reference methods or established clinical diagnoses, but the specifics are not in this letter.
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The sample size for the training set: This information is not present. IVDs are typically "trained" through assay development and validation, not in the same way an AI algorithm has a distinct "training set."
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How the ground truth for the training set was established: This information is not present.
In summary, this document is a regulatory approval and confirms the device's substantial equivalence to existing devices. It does not provide the underlying technical and clinical study details that would address the requested questions about acceptance criteria and performance studies. Those details would typically be found in the full 510(k) submission or associated technical documentation, which is not provided here.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the caduceus.
9 1399 JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re: K991409 Trade Name: K-ASSAY Rheumatoid Factor Regulatory Class: II Product Code: DHR Dated: April 21, 1999 Received: April 22, 1999
Dear Mr. Getty:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
K-ASSAY Rheumatoid Factor. Device Name:
Indications For Use:
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The K-ASSAY Rheumatoid Factor is intended to be used for the quantitative determination of human rheumatoid factor in human serum by immunoturbidimetric assav.
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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991405
Prescription Use
(Per 21 CFR 801.109)
OR
3
Over-The-Counter Use
Optional Format 1-2-96)
§ 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).