17 B-ESTRADIOL (ELISA)

K973901 · Kmi Diagnostics, Inc. · CHP · Nov 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973901
• Device Name: 17 B-ESTRADIOL (ELISA)
• Applicant: Kmi Diagnostics, Inc.
• Product Code: CHP · Clinical Chemistry
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1260
• Device Class: Class 1

Intended Use

The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Device Story

The Estradiol ELISA Test Kit is an in vitro diagnostic assay used to measure estradiol levels in human serum and plasma samples. The device utilizes an Enzyme-Linked Immunosorbent Assay (ELISA) principle to quantify the concentration of the estrogenic steroid. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a quantitative measurement of estradiol, which healthcare providers use to assist in the diagnosis and management of hormonal sexual disorders and to evaluate placental function during complicated pregnancies. The test provides clinical information to support medical decision-making regarding endocrine health and pregnancy monitoring.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic ELISA (Enzyme-Linked Immunosorbent Assay) kit for quantitative detection of estradiol in serum and plasma. Class I device, product code CHP.

Indications for Use

Indicated for in vitro determination of estradiol in human serum and plasma for the diagnosis and treatment of hormonal sexual disorders and assessment of placental function in complicated pregnancies.

Regulatory Classification

Identification

An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

**NOV 24 1997**

Mark A. Kowal . President KMI Diagnostics, Inc. 818 51st Avenue, NE Suite 101 55421 Minneapolis, Minnesota

Re : K973901 17 ß-Estradiol (ELISA) Regulatory Class: I .. . Product Code: CHP October 10, 1997 Dated: 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 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 General regulation (21 CFR Part 820) and that, Devices: 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 requlations.

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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 requlation (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 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 Litman

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 Sist Ave. NE Suite 101 Minneapolis, MN 55421 USA

Attachment I

Device Name: Estradiol ELISA Test Kit

Indications for Use

The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

(Division Sign-Off)
Division of Clinical Laboratory Degies
510(k) Number. k973930

Mark Q. Kousf

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

rrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Phone: [phone]

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