PROGESTERONE ELISA

K973898 · Kmi Diagnostics, Inc. · JLS · Nov 13, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973898
• Device Name: PROGESTERONE ELISA
• Applicant: Kmi Diagnostics, Inc.
• Product Code: JLS · Clinical Chemistry
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1620
• Device Class: Class 1

Intended Use

The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Device Story

The IBL Progesterone ELISA Test Kit is an in vitro diagnostic device used to quantify progesterone levels in human serum and plasma samples. It operates on the enzyme-linked immunosorbent assay (ELISA) principle, a standard laboratory technique for measuring hormone concentrations. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Healthcare providers use the resulting quantitative progesterone measurements to assist in the clinical diagnosis and management of patients presenting with suspected ovarian or placental dysfunction. The device provides objective data that informs clinical decision-making regarding hormonal health and reproductive status.

Clinical Evidence

No clinical data provided; the submission relies on substantial equivalence to existing legally marketed devices.

Technological Characteristics

The device utilizes enzyme-linked immunosorbent assay (ELISA) technology for the quantitative measurement of progesterone. It is an in vitro diagnostic test kit designed for laboratory use. No specific materials, software, or connectivity features are described.

Indications for Use

Indicated for the measurement of progesterone in human serum and plasma to aid in the diagnosis and treatment of ovarian or placental disorders.

Regulatory Classification

Identification

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 3 1997

Mr. Mark A. Kowal President/CEO KMI Diagnostics, Inc. 818 5185 Avenue, N.E. Suite 101 Minneapolis, Minnesota 55421

K973898 Re : Trade Name: IBL Progesterone ELISA Test Kit Requlatory Class: I Product Code: JLS Dated: October 10, 1997 Received: October 14, 1997

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 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlatory 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 [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 diagnostic 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 requlation 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 at [phone] or at its internet address "http://www.fda.qov/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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KMI Diagnostics, Inc. 818 51st Ave. NE Suite 101 Minneapolis, MN 55421 USA

Attachment I

Device Name: Progesterone ELISA Test Kit

Indications for Use

The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | OR | Over-The-Counter Use | <div> <span style="text-decoration: overline;"> </span> </div> |
|----------------------|----------------------------------------------------------------|----|--------------------------|----------------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

510(k) Number: K973898
Phone: [phone]