AUTOHDL CHOLESTEROL REAGENT SET

K992002 · Pointe Scientific, Inc., · LBR · Aug 5, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992002
• Device Name: AUTOHDL CHOLESTEROL REAGENT SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: LBR · Clinical Chemistry
• Decision Date: Aug 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Device Story

Liquid autoHDL™ Cholesterol Reagent Set is an in vitro diagnostic reagent kit for quantitative measurement of HDL cholesterol in serum or plasma samples. Used in clinical laboratory settings by qualified technologists. Reagents facilitate chemical reaction allowing spectrophotometric measurement of HDL cholesterol levels. Results assist clinicians in identifying patients at increased risk for coronary heart disease based on low HDL levels. Device provides quantitative data to support clinical diagnostic decision-making regarding cardiovascular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent set for quantitative chemical analysis of HDL cholesterol. Operates via spectrophotometric measurement. Intended for professional laboratory use.

Indications for Use

Indicated for the quantitative determination of HDL cholesterol in serum or plasma in patients being assessed for coronary heart disease risk. For use by qualified laboratory technologists in a diagnostic laboratory setting.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a symbol or abstract representation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 5 1999

Mr. William F. Walters, Jr. Vice President - Technical Director Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146

Re: K992002

> Trade Name: Liquid autoHDL™ Cholesterol Reagent Set Regulatory Class: II Product Code: LBR Dated: June 8, 1999 Received: June 15, 1999

Dear Mr. Walters:

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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## 510 (k) Number (if known):_ Inknown at this ilmis

Device Name:_autoHDL Cholesterol Reagent Set

Indications for use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Jean Corpy

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K 992002

(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)