(155 days)
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.
Not Found
This FDA 510(k) clearance letter for the Lifestream PLUS Cholesterol Monitor provides very limited information regarding the performance study and acceptance criteria. It primarily focuses on the regulatory aspects of device clearance. However, based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter does not include a table of acceptance criteria or reported device performance metrics for the Lifestream PLUS Cholesterol Monitor. It merely states that the device is "substantially equivalent" to legally marketed predicate devices. To determine acceptance criteria for a cholesterol monitor, one would typically look for:
- Accuracy/Bias: How close are the device's readings to a reference method (e.g., laboratory wet chemistry)?
- Precision/Reproducibility: How consistent are the device's readings when measured repeatedly on the same sample?
- Linearity/Measuring Range: Does the device accurately measure across a defined range of cholesterol concentrations?
- Interference: What substances (e.g., triglycerides, bilirubin) might affect the accuracy of the readings?
- User Performance Metrics: For an over-the-counter device, ease of use and accuracy when used by laypersons are important.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth. For a cholesterol monitor, the ground truth would typically be established by a reference laboratory using an established, highly accurate method.
4. Adjudication Method
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Given this is an in-vitro diagnostic device (cholesterol monitor) and not an imaging or diagnostic interpretation aid for human readers, a MRMC comparative effectiveness study is not applicable or mentioned.
6. Standalone Performance Study
While the letter implies a performance evaluation was done to prove substantial equivalence, it does not explicitly describe a standalone (algorithm only) performance study in terms of specific metrics like sensitivity, specificity, or accuracy. It only states that the device measures total cholesterol in fingerstick whole blood samples. For such a device, the "standalone performance" is essentially the accuracy and precision of the meter itself when performing the biochemical assay.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for a cholesterol monitor, the ground truth would almost certainly be established using a laboratory reference method (e.g., enzymatic colorimetric assays performed on venous plasma by a certified clinical laboratory). This is considered the gold standard for cholesterol measurements.
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set. For a simple in-vitro diagnostic device like a cholesterol monitor, "training sets" in the typical AI sense are less common. Device calibration and internal validation would be performed using a variety of known concentration samples.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for any training set was established. As mentioned in point 7, it would likely involve a laboratory reference method to establish known cholesterol concentrations.
In summary, the provided FDA 510(k) clearance letter primarily focuses on the administrative and regulatory aspects of device clearance through the "substantial equivalence" pathway. It does not contain the detailed technical performance study information typically found in clinical study reports or scientific publications. To obtain such information, one would need to refer to the actual 510(k) submission documentation if it were publicly accessible, or scientific literature published by the manufacturer.
{0}------------------------------------------------
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).
{1}------------------------------------------------
Page 2
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
{2}------------------------------------------------
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
Page 1 of
-510(k)
§ 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.