(42 days)
The K-ASSAY Transferrin Assay is intended to be used for the quantitative determination of Transferrin in human serum by immunoturbidimetric assay. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. FOR IN VITRO DIAGNOSTIC USE.
Not Found
The provided document (K993537) is a 510(k) clearance letter for the K-ASSAY Transferrin device, which is an in vitro diagnostic assay. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML medical devices.
Instead, this document grants clearance based on substantial equivalence to a predicate device. The information provided is primarily regulatory in nature, indicating that the FDA has reviewed the manufacturer's submission and determined the device can be legally marketed.
Therefore, I cannot directly extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document because it is not present. The questions you've asked are typically addressed in a clinical or performance study report, which would be part of the 510(k) submission but is not included in the clearance letter itself.
To answer your questions, one would need to access the actual 510(k) submission (K993537) and look for the performance data section, which is not publicly available in this format.
Based on the provided text, I can only state that this document does not contain the requested information about acceptance criteria and performance studies in the context of an AI/ML device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 30 1999
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re: K993537 Trade Name: K-ASSAY Transferrin Regulatory Class: II Product Code: DDG Dated: October 13, 1999 Received: October 19, 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: K-ASSAY Transferrin.
Indications for Use:
The K-ASSAY Transferrin Assay is intended to be used for the quantitative determination of Transferrin in human serum by immunoturbidimetric assay. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. FOR IN VITRO DIAGNOSTIC USE.
(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 | K973537 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use _____ |
|---|---|---|---|
| --------------------------------------- | --------------------------------------------------- | ---- | ---------------------------------------------------------------------------- |
Optional Format 1-2-96)
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).