(73 days)
As a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays.
The KAMIYA RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays. Two levels of the KAMIYA RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).
This document is a 510(k) summary for the KAMIYA RF Control Set, an in vitro diagnostic device used to monitor the performance of RF immunoturbidimetric assays. The submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, de novo clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML devices. Therefore, a direct mapping to all requested fields for AI/ML device studies is not possible.
Here's an analysis based on the provided text, addressing the relevant points and noting where direct information is unavailable due to the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Sigma Immunology Control, K851202) | Exhibits similar "within run and between day precision and reaction characteristics for the analyte" as the predicate device. |
| Consistency as a test sample of known concentration | The device is described as "a consistent test sample of known concentration." Specific quantitative data on consistency is not provided beyond the precision and reaction characteristics. |
| Traceability of assigned RF values | Assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. |
| Stability | Stable for at least 1 year (unopened) and 2 weeks (after reconstitution). |
| Negative for HBsAg, HCV, and HIV antibodies in human serum | Human serum used is tested and found negative for these analytes. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size in the context of a traditional clinical study with patient samples. The evaluation is based on the performance of the control material itself in laboratory settings.
- Sample Size: Not explicitly stated for testing precision or reaction characteristics.
- Data Provenance: Not explicitly stated, however, the product is from KAMIYA BIOMEDICAL COMPANY in Seattle, WA, USA. The testing would have been conducted internally as part of the validation for the 510(k) submission. This is a retrospective evaluation against an existing predicate device rather than a prospective study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. The "ground truth" for a control material is its assigned value and its performance characteristics (precision, linearity, etc.) when tested against a reference method or predicate device. This isn't a diagnostic device requiring expert interpretation of results on patient samples to establish ground truth.
4. Adjudication method for the test set
Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations of patient data. The evaluation is based on laboratory measurements against a predicate device.
5. 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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the KAMIYA RF Control is its assigned RF values, traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum, and its demonstrated precision and reaction characteristics in comparison to the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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KAMIYA BIOMEDICAL COMPANY
910 Industry Drive, Seattle, WA 98188 USA
TEL: (206) 575-8068 FAX:(206) 575-8094
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K984045
October 30, 1998 Date:
- Colin Getty Submitted by: KAMIYA BIOMEDICAL COMPANY 910 Industry Drive, Seattle WA 98188 TEL: 206-575-8068; FAX: 206-575-8094
Product: RF Control Set
The KAMIYA RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays.
Two levels of the KAMIYA RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).
The safety and effectiveness of the KAMIYA RF Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202). The KAMIYA RF Control exhibits similar within run and between day precision and reaction characteristics for the analyte.
10/30/98
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Public Health Service
JAN 25 1999
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K984045 Trade Name: RF Control Set for Immunoturbidimetric Assays Regulatory Class: II Product Code: DHR Dated: October 30, 1998 Received: November 13, 1998
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 vours.
Steven Putman
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
K 984045 510(k) Number (if known): __
RF Control Set Device Name:
Indications For Use:
As a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter C. Molini
K68404
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Format 1-2-96)
10/30/98
§ 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).