PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR

K993096 · Lifestream Technologies, Inc. · CHH · Dec 20, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993096
• Device Name: PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
• Applicant: Lifestream Technologies, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information

Device Story

Privalink Software accessory functions with Lifestream Cholesterol Monitor; professional-use point-of-care device. Input: total cholesterol measurements from fingerstick whole blood samples. Software processes data to provide personalized health-related information to clinicians. Output: health information used to assist in coronary heart disease risk detection and management of patients on lipid-lowering therapy. Used in clinical settings by healthcare professionals to support clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software accessory for in vitro diagnostic cholesterol monitor. Point-of-care use. Measurement range 150-300 mg/dL.

Indications for Use

Indicated for total cholesterol measurement in fingerstick whole blood to aid in detecting coronary heart disease risk and managing patients on lipid-lowering therapy. Measurement range: 150-300 mg/dL. Prescription use only.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 0 1999

Mr. Jackson B. Connolly Vice President of Product Development Lifestream Technologies, Inc. 510 Clearwater Loop Suite 101 Post Falls, Idaho 83854

Re: K993096

> Trade Name: Privalink Software Accessory to the Lifestream Cholesterol Monitor Regulatory Class: I reserved Product Code: CHH Dated: October 6, 1999 Received: October 7, 1999

Dear Mr. Connolly:

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/cdrlvdsma/dsmamain.html".

Sincerely yours.

Steven Putman

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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# K993096 PRIVALINK SOFTWARE ACCESSORY

## INTENDED USE/INDICATIONS FOR USE

#### INTENDED USE

The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information

### INDICATIONS FOR USE

Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs.

The measurement range for the Cholestron is 150 - 300 mg/dL.

Prescription Use

Carol Benson for Jean Cooper DVM
(Division Sign-Off)