TESTOTERONE ELISA

K973900 · Kmi Diagnostics, Inc. · CDZ · Feb 24, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973900
• Device Name: TESTOTERONE ELISA
• Applicant: Kmi Diagnostics, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

The IBL Testosterone assay is an Enzyme-Immunoassay (EIA) for the quantitative determination of Testosterone in human serum or plasma.

Device Story

Testosterone ELISA Test Kit is an enzyme-immunoassay (EIA) for quantitative measurement of testosterone in human serum or plasma. Used in clinical laboratory settings by trained laboratory personnel. Input consists of patient serum or plasma samples. Device utilizes enzyme-linked immunosorbent assay technology to detect testosterone levels. Output is a quantitative concentration value of testosterone, typically provided to physicians to assist in the assessment of endocrine function and hormonal status. Results aid in clinical decision-making regarding diagnosis and monitoring of conditions related to testosterone levels.

Clinical Evidence

No clinical data provided in the document; the document is a 510(k) clearance letter.

Technological Characteristics

Enzyme-Immunoassay (EIA) technology; quantitative diagnostic test; in vitro diagnostic device.

Indications for Use

Indicated for the quantitative determination of Testosterone in human serum or plasma for clinical diagnostic use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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