(206 days)
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Not Found
No
The summary describes a standard in vitro diagnostic device for measuring cholesterol and mentions "personalized health related information" provided by accessory software, but there is no mention of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic (IVD) device used for measurement of total cholesterol to aid in detection and management of patients. It does not provide therapy itself.
Yes
The "Intended Use" section explicitly states, "The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device".
No
The device is described as an in vitro diagnostic device that measures total cholesterol in fingerstick whole blood samples. This inherently involves a physical component (the monitor) to perform the measurement, even if it uses software (Privalink Software accessory) for data processing and personalized information. The core function relies on a hardware measurement device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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..."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
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
Product codes
CHH
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
professional-use, point-of-care
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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)