(46 days)
The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human serum. Complement is a group of serum proteins which destroy cells by immunologically mediated lysis. Quantitative determination of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.
Not Found
This is a 510(k) clearance letter for the K-ASSAY C4 device, dated November 30, 1999. It states that the device is substantially equivalent to legally marketed predicate devices. This type of document, particularly one from 1999, typically does not contain the detailed study information you are requesting. The focus of a 510(k) is to demonstrate substantial equivalence, not to provide comprehensive performance study results in the same way a PMA or a more recent device submission might.
Therefore, many of the requested data points (acceptance criteria, specific performance metrics, sample sizes, ground truth details, expert qualifications, MRMC studies, etc.) are not available in this document.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria or reported device performance metrics. The FDA letter grants clearance based on substantial equivalence to a predicate device, meaning detailed performance data against specific acceptance criteria is not typically outlined in the clearance letter itself. Such data would be found in the 510(k) submission itself, which is not provided here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in this document.
3. 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):
Not applicable/Not available in this document. For an in-vitro diagnostic device like K-ASSAY C4, "ground truth" would typically be established by reference methods or clinical diagnosis, not by experts adjudicating image data. However, the details of how any reference range or accuracy was established are not present here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not available in this document.
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. The K-ASSAY C4 is an in-vitro diagnostic assay for quantitative determination of C4, not an AI-assisted diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As an in-vitro diagnostic assay, its performance is inherently "standalone" in its measurement, but the specific validation study details are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For an in-vitro diagnostic assay like K-ASSAY C4 (which quantifies C4 in human serum or plasma), "ground truth" for validation would typically be established through reference methods, comparison to established predicate devices, and potentially clinical correlation with disease states known to affect C4 levels. However, the specifics of how this was established for this particular submission are not described in this document.
8. The sample size for the training set:
Not applicable/Not available in this document. This is a clearance letter for a 1999 device, likely not an AI/ML device that would refer to "training sets."
9. How the ground truth for the training set was established:
Not applicable/Not available in this document. (See above, not an AI/ML device in the context of "training set").
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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 eagle with three horizontal lines representing its wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 300 1999
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K993481 Re: Trade Name: K-ASSAY C4 Regulatory Class: II
Product Code: DBI Dated: October 11, 1999 Received: October 14, 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 OS 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 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
4993481 510(k) Number (if known): __
Device Name: K-ASSAY C4.
Indications for Use:
The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human r no A ACON - O Tributy load Complement is a group of serum proteins which destroy scraft by inmunotarelained at these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.
(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 | K993481 |
| Prescription Use | OR | Over-The-Counter Use ______ | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
Optional Format 1-2-96
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).