(133 days)
The IBL Testosterone assay is an Enzyme-Immunoassay (EIA) for the quantitative determination of Testosterone in human serum or plasma.
Testosterone ELISA Test Kit
This document is a 510(k) clearance letter from the FDA for a Testosterone ELISA Test Kit. It does not contain the detailed information required to answer the questions about acceptance criteria, study design, and performance metrics for a device that typically involves AI or image analysis.
The letter explicitly states:
"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... to devices marketed in interstate commerce prior to May 28, 1976..."
This is a substantial equivalence (SE) determination for a laboratory diagnostic test kit, not a performance study for a device evaluated against specific acceptance criteria in the way an AI-powered device would be. The clearance is based on the device being substantially equivalent to a predicate device already on the market, not on fulfilling novel performance criteria through a new study as would be required for a de novo or PMA submission.
Therefore, the specific information requested in points 1-9 (acceptance criteria table, sample sizes for test/training, expert qualifications, ground truth methods, MRMC studies, standalone performance with AI, etc.) is not present in this document. This document confirms regulatory clearance based on substantial equivalence, which is a different type of review.
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FEB 2 4 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark A. Kowal . President KMI Diagnostics, Inc. 818 51st Avenue, NE Suite 101 Minneapolis, Minnesota 55421-1746
Re : K973900 Testosterone ELISA Test Kit Regulatory Class: । Product Code: CDZ January 20, 1998 Dated: Received: January 28, 1998
Dear Mr. Kowal:
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 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 The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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 diaqnostic 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/dsmamain.html",
sincerely yours,
Steven Sitman
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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KMI Diagnostics, Inc. 818 51st Ave. NE Suite 101 Minneapolis, MN 55421 USA
Attachment I
Device Name: Testosterone ELISA Test Kit
Indications for Use
The IBL Testosterone assay is an Enzyme-Immunoassay (EIA) for the quantitative determination of Testosterone in human serum or plasma.
Mala C. Koman
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973950
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.