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

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.

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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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K033899

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was the addition of the health risk assessment (HRA) module to the product and its labeling.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.