(44 days)
The K-ASSAY RF Calibrator Set is intended to be used for the calibration of the K-ASSAY RF immunoturbidimetric assay for quantitating Rheumatoid Factor in serum samples.
K-ASSAY Rheumatoid Factor Calibrator Set
This document is a 510(k) clearance letter from the FDA for a device called "K-ASSAY Rheumatoid Factor Calibrator Set." It is not a study report or a pre-market approval application with detailed device performance data. Therefore, the information requested in your prompt regarding acceptance criteria and study details cannot be fully extracted from this document.
The document states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the criteria for substantial equivalence, primarily by demonstrating that it is as safe and effective as a legally marketed predicate device.
However, the specific "acceptance criteria" for performance metrics and the "study that proves the device meets the acceptance criteria" with the level of detail you've requested are not provided in this regulatory clearance letter. Such information would typically be found in the 510(k) submission itself, which is not this document.
Based on the provided document, here's what can be inferred or explicitly stated, and what cannot:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. This letter does not contain a table of acceptance criteria or performance metrics for the K-ASSAY RF Calibrator Set. The substantial equivalence determination implies that the device's performance was deemed acceptable in comparison to a predicate, but the specific numerical targets or results are not detailed here.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be retrieved. The document doesn't mention any specific test set sample sizes or data provenance for a study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be retrieved. This information is related to a clinical study, which is not detailed in this clearance letter.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be retrieved. This information is related to a clinical study, which is not detailed in this clearance letter.
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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:
- Not applicable. This is an in-vitro diagnostic calibrator set, not an AI-assisted diagnostic imaging device. MRMC studies are typically for imaging devices with human interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Likely applicable, but details unknown. As a calibrator set for an immunoturbidimetric assay, its performance would be evaluated in a "standalone" analytical context (i.e., how accurately it calibrates the assay system), but the specifics of such a study are not in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be retrieved. For a calibrator, "ground truth" would likely relate to reference standards or known concentrations, but the specifics are not mentioned here.
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The sample size for the training set:
- Not applicable/Cannot be retrieved. As a calibrator set, it typically doesn't involve "training sets" in the machine learning sense. If there were method development or validation sets, their sizes are not disclosed.
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How the ground truth for the training set was established:
- Not applicable/Cannot be retrieved. Similar to point 8, this concept doesn't directly apply as described for a calibrator. Ground truth for calibration materials would involve traceability to reference measurement procedures or certified reference materials, but the specific methods are not provided.
In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device for a calibrator set. It does not provide the detailed scientific study data, performance metrics, or clinical trial information that would allow full answers to your questions. This detailed information would have been part of the manufacturer's 510(k) submission to the FDA.
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JUN 10 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K991467 Trade Name: K-ASSAY Rheumatoid Factor Calibrator Set Regulatory Class: II Product Code: DHR Dated: April 21, 1999 Received: April 27, 1999
Dear Mr. Getty:
Re:
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 Butman
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 RF Calibrator Set. Device Name:
Indications For Use:
The K-ASSAY RF Calibrator Set is intended to be used for the calibration of the K-ASSAY RF immunoturbidimetric assay for quantitating Rheumatoid Factor in serum samples.
(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 | K991467 |
| 510(k) Number |
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) | Optional Format 1-2-96) |
RF Calibrator 510(k)
4/21/99
§ 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).