(155 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
Explanation: This device is an in vitro diagnostic device used for measurement and detection, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Lifestream Cholesterol Monitor is an over-the-counter in vitro diagnostic device."
No
The intended use clearly describes an "in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples." This implies the use of a physical device (likely a meter and test strips) to perform the measurement, which is not a software-only function.
Yes, based on the provided information, the Lifestream Cholesterol Monitor is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "over-the-counter in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples."
- Nature of Measurement: It measures a substance (total cholesterol) in a sample taken from the body (fingerstick whole blood) outside of the body ("in vitro").
- Purpose: The measurement aids in the detection of risk for coronary heart disease and provides information for managing cholesterol levels.
These characteristics align with the definition of an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NFX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1175 Cholesterol (total) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human figures in profile, arranged in a stack. The figures are black and have a flowing, wave-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the figures.
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)