(133 days)
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No
The summary describes a standard immunoassay kit for measuring testosterone levels, with no mention of AI or ML technologies.
No
Explanation: This device is an assay for the quantitative determination of Testosterone, which is a diagnostic purpose rather than a therapeutic one. It analyzes a substance in the body but does not treat or prevent a disease.
Yes
The device "determine[s] the quantitative determination of Testosterone in human serum or plasma," which is used as a diagnostic indicator for various health conditions.
No
The device description explicitly states "Testosterone ELISA Test Kit," which is a hardware-based laboratory assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Testosterone in human serum or plasma." This means it's used to test samples taken from the human body (in vitro) to diagnose or provide information about a person's health status.
- Device Description: The description "Testosterone ELISA Test Kit" further confirms it's a kit designed for laboratory testing of biological samples.
These points align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IBL Testosterone assay is an Enzyme-Immunoassay (EIA) for the quantitative determination of Testosterone in human serum or plasma.
Product codes
CDZ
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
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected and appear to be part of a single, flowing design.
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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Image /page/2/Picture/0 description: The image shows a logo with the letters "KMI" in a bold, stylized font. The letters are all capitalized and appear to be slightly slanted to the right. The logo is black and the background is white. The letters are thick and have a slightly rough or textured appearance.
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