LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR

K033899 · Lifestream Technologies, Inc. · NFX · May 20, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033899
• Device Name: LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
• Applicant: Lifestream Technologies, Inc.
• Product Code: NFX · Clinical Chemistry
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The Lifestream Cholesterol Monitor is an over-the-counter in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples. Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and provide information for individuals who are attempting to lower their levels through diet and exercise, or who are under a physician's care with lipid lowering drugs.

Device Story

Lifestream PLUS Cholesterol Monitor is an in vitro diagnostic device for home use. It measures total cholesterol levels from fingerstick whole blood samples. The device provides quantitative results to individuals to assist in monitoring cholesterol levels for heart disease risk management, lifestyle changes (diet/exercise), or tracking efficacy of physician-prescribed lipid-lowering medications. Users operate the device independently to obtain immediate feedback on their cholesterol status.

Clinical Evidence

Bench testing and design control verification/validation activities performed per risk analysis; no clinical data provided.

Technological Characteristics

In vitro diagnostic device for total cholesterol measurement; utilizes fingerstick whole blood samples; intended for over-the-counter use.

Indications for Use

Indicated for over-the-counter use by individuals to measure total cholesterol in fingerstick whole blood. Aids in detecting risk for coronary heart disease and monitoring cholesterol levels during diet, exercise, or physician-managed lipid-lowering drug therapy.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 0 2004

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

Re: k033899

> Trade/Device Name: Lifestream PLUS Cholesterol Monitor Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: NFX Dated: April 3, 2004 Received: May 4, 2004

Dear Mr. Connolly:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 Fedcral Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (sce above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K-033899

Device Name: Lifestream PLUS Cholesterol Monitor

Indications For Use:

The Lifestream Cholesterol Monitor is an over-the-counter in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples. Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and provide information for individuals who are attempting to lower their levels through diet and exercise, or who are under a physician's care with lipid lowering drugs.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

R. Chelon - Cr. Jim Cooper

Division Sign-C

Office of In Vitro Diagnostic Device Evaluation and Safety 338999

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-510(k)