DIRECT HDL-CHOLESTEROL REAGENT

K990581 · Kamiya Biomedical Co. · LBS · Jun 18, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990581
• Device Name: DIRECT HDL-CHOLESTEROL REAGENT
• Applicant: Kamiya Biomedical Co.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jun 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders. The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

Device Story

K-ASSAY Direct HDL-Cholesterol system consists of a reagent and calibrator for quantitative in vitro measurement of HDL-cholesterol in serum or plasma. Used in clinical laboratory settings by trained personnel to assist in diagnosing and managing lipid disorders. Reagent facilitates direct measurement of HDL-cholesterol without pretreatment or centrifugation. Calibrator ensures assay accuracy. Healthcare providers use results to assess patient lipid profiles and guide therapeutic decisions.

Technological Characteristics

In vitro diagnostic reagent and calibrator for HDL-cholesterol measurement. Direct assay method eliminates need for sample pretreatment. Intended for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for quantitative in vitro determination of HDL-cholesterol in serum or plasma to aid in diagnosis and treatment of lipid disorders. For prescription use.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Submission Summary (Full Text)

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JUN 18 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

K990581 Re:

> Trade Name: K-Assay Direct HDL-Cholesterol Reagent K-Assay Direct HDL-Cholesterol Calibrator Regulatory Class: I reserved (Cholesterol Reagent) II (Cholesterol Calibrator) Product Code: LBS, JIS Dated: June 7, 1999 Received: June 11, 1999

Dear Mr. Getty:

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 vour 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/cdrlv/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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K 990581 _________________________________________________________________________________________________________________________________________

K-ASSAY Direct HDL-Cholesterol reagent and calibrator. Device Name:

## Indications For Use:

The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders.

The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <img alt="Checkmark" src="checkmark.png"/> </div> |
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OR

| Over-The-Counter Use | |
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Optional Format 1-2-96)Direct HDL-Cholesterol Reagent and Calibrator 510(k)

6/07/99