CALCITONIN

K990073 · Kmi Diagnostics, Inc. · JKR · May 11, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990073
• Device Name: CALCITONIN
• Applicant: Kmi Diagnostics, Inc.
• Product Code: JKR · Clinical Chemistry
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1140
• Device Class: Class 2

Indications for Use

The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. This assay is intended for in vitro diagnostic use only.

Device Story

Calcitonin ELISA Test Kit is an in vitro diagnostic assay for measuring calcitonin levels in human plasma and serum. Used in clinical laboratory settings by trained personnel to assist in diagnosing and monitoring thyroid and parathyroid disorders, such as carcinoma and hyperparathyroidism. The device utilizes enzyme immunoassay technology to quantify calcitonin concentrations. Results are provided to clinicians to inform diagnostic and therapeutic decision-making for patients with suspected thyroid or parathyroid pathology.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for quantitative measurement of calcitonin in serum and plasma. In vitro diagnostic kit format.

Indications for Use

Indicated for in vitro diagnostic measurement of calcitonin in human plasma and serum to aid in the diagnosis and treatment of thyroid and parathyroid gland diseases, including carcinoma and hyperparathyroidism.

Regulatory Classification

Identification

A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Submission Summary (Full Text)

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MAY 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark A. Kowal President and CEO KMI Diagnostics, Inc. 818 51st Avenue, N.E., Suite 101 Minneapolis, Minnesota 55421-1746

Re: K990073 Trade Name: Calcitonin ELISA Test Kit Regulatory Class: II Product Code: JKR Dated: March 18, 1999 Received: March 22, 1999

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 legally marketed predicate 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 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 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 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/dsma/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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Page of

510(k) Number (if known):_ K9900 73

## Device Name: Calcitonin ELISA Test Kit

## Indications for Use

The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. This assay is intended for in vitro diagnostic use only.

Jean Coogen
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K996673

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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