(44 days)
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No
The summary describes a calibrator set for an immunoturbidimetric assay, which is a chemical/biological measurement technique. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of AI/ML.
No
The device is a calibrator set used for an assay to quantify Rheumatoid Factor in serum samples, which is a diagnostic function, not a therapeutic one.
Yes
The device is a calibrator set for an assay that quantifies Rheumatoid Factor in serum samples, which is used to diagnose or monitor conditions. Therefore, it supports a diagnostic process.
No
The device description clearly states "K-ASSAY Rheumatoid Factor Calibrator Set," which implies a physical set of calibrators, not a software-only product. The intended use also describes calibration of an "immunoturbidimetric assay," which is a laboratory test involving physical reagents and equipment.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitating Rheumatoid Factor in serum samples." Serum is a biological sample taken from the body, and the assay is performed in vitro (outside the body) to analyze components within that sample.
- Device Description: The device is a "Calibrator Set" for an "immunoturbidimetric assay." Assays are laboratory tests performed in vitro to measure substances in biological samples. Calibrators are essential components used in many in vitro diagnostic tests to ensure accurate measurements.
The combination of analyzing a biological sample (serum) in vitro using an assay and calibrators strongly indicates that this device falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DHR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a clear and recognizable emblem.
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
2
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