(21 days)
As a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.
The KAMIYA Immunology Control is a liquid-stable, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents. Two levels of the KAMIYA Immunology Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to CV and HIV. The assigned values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The product is stable for at least 1 year (unopened) and 1 month (after opening).
The Kamiya Biomedical Company's Immunology Control is a liquid-stable, human serum-based, assayed control intended for monitoring the performance of immunoturbidimetric assays for various constituents.
1. Acceptance Criteria and Reported Device Performance:
The document states that the safety and effectiveness of the KAMIYA Immunology Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202). The key acceptance criteria and reported performance are based on comparison to this predicate device.
| Acceptance Criteria | Reported Device Performance (KAMIYA Immunology Control) |
|---|---|
| Substantial Equivalence to Predicate Device (Sigma Immunology Control K851202) | Achieved |
| Similar within-run precision for 10 analytes tested | Demonstrated |
| Similar between-day precision for 10 analytes tested | Demonstrated |
| Similar reaction characteristics for 10 analytes tested | Demonstrated |
| Stability (unopened) | At least 1 year |
| Stability (after opening) | At least 1 month |
| Negative for HBsAg, antibody to CV, and HIV (human serum source) | Tested and found negative |
| Traceable to CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum (assigned values) | Achieved |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for the performance evaluation. It mentions "10 analytes tested," implying that the comparison for precision and reaction characteristics was performed across these analytes.
The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission, it would typically involve prospective testing conducted by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information about the number of experts used or their qualifications for establishing ground truth as it relates to the performance study. The ground truth for the assigned values is stated to be traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum, which implies established, standardized reference methods and materials are used.
4. Adjudication Method:
The document does not mention an adjudication method for a test set in the context of expert consensus or disagreement. The evaluation relies on direct comparisons of performance characteristics against a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic control, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.
6. Standalone Performance Study:
A standalone performance study was performed in the sense that the KAMIYA Immunology Control's own precision and reaction characteristics were measured and then compared to those of the predicate device to demonstrate substantial equivalence. The "algorithm" here refers to the function of the control itself, rather than a software algorithm.
7. Type of Ground Truth Used:
The ground truth for the assigned values of the control is established by traceability to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. For the performance evaluation (precision and reaction characteristics), the "ground truth" is effectively derived from the established performance of the legally marketed Sigma Immunology Control (K851202), against which the new device is compared for substantial equivalence.
8. Sample Size for the Training Set:
This concept is not applicable. The device is a diagnostic control, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable as there is no training set for this device.
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Kg8-3130
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.
K983130 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
September 2, 1998 Date:
- Colin Getty Submitted by: KAMIYA BIOMEDICAL COMPANY 910 Industry Drive. Seattle WA 98188 TEL: 206-575-8068; FAX: 206-575-8094
Product: Immunology Control
The KAMIYA Immunology Control is a liquid-stable, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.
Two levels of the KAMIYA Immunology Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to CV and HIV. The assigned values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The product is stable for at least 1 year (unopened) and 1 month (after opening).
The safety and effectiveness of the KAMIYA Immunology Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202) manufactured by Gilford. The KAMIYA Immunology Control shows similar within run and between day precision and reaction characteristics for the 10 analytes tested.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by a series of curved lines that suggest a face and body.
SEP 2 9 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re : K983130 Trade Name: Immunology Control Regulatory Class: I Product Code: JJY Dated: September 4, 1998 Received: September 8, 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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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Page 2
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 leqally 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 labelinq 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 requlation 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 Autman
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
983130 510(k) Number (if known):
Device Name: Immunology Controls
Indications For Use:
As a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Martin
Division Sign-Off Division of Clinical Laborator 510(k) Number
Prescription Use
(Per 21 CFR 801.109) V
OR
Over-The-Counter Use
Optional Format 1-2-96)
Liquid Immunology Control
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.