(200 days)
Not Found
No
The device description and performance studies focus on a chemical reaction and spectrophotometric measurement, with no mention of AI or ML. The analysis of results is based on statistical correlations and logistic regression, not AI/ML algorithms.
No
This device is an in vitro diagnostic test used for quantification and risk assessment, not for direct treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that Cholesterol 1,2,3TM is "an in vitro diagnostic test for the quantification of skin cholesterol" and "Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options." This clearly indicates its role in diagnosis and risk assessment.
No
The device description explicitly states that the device is a "spectrophotometer in conjunction with the Cholesterol 1,2,3™ reagents," indicating the presence of hardware (spectrophotometer) and chemical components (reagents) in addition to any potential software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that Cholesterol 1,2,3TM is an "in vitro diagnostic test for the quantification of skin cholesterol."
- Device Description: The "Device Description" also reinforces this by stating the device is "intended for use in the quantitative determination of cholesterol in the epidermal layer of the skin."
- Mechanism: The description details a chemical reaction using a "detector reagent" and "indicator reagent" that reacts with a biological sample (skin cholesterol) to produce a measurable result (color intensity). This is a hallmark of in vitro diagnostic tests.
- Purpose: The test is used to provide information about a patient's health status (skin cholesterol levels) to aid in the diagnosis and management of a disease (coronary heart disease). This aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
Intended Use: Cholesterol 1,2,3™ is an in vitro diagnostic test for the quantification of skin cholesterol. Cholesterol 1,2,3™ uses a detector reagent that reacts with skin cholesterol in proportion to the amount of cholesterol on the surface of the epidermis. An indicator reagent (horseradish peroxidase substrate) is added and color allowed to develop. Color intensity is proportional to the amount of bound skin cholesterol in the palmar surface of the skin. The color intensity (hue) can be measured objectively by use of a handheld reflectance spectrophotometer.
Indications for Use: Skin cholesterol as measured by Cholesterol 1,2,3™ can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
Product codes (comma separated list FDA assigned to the subject device)
LBS
Device Description
The Cholesterol 1,2,3™ spectrophotometer in conjunction with the Cholesterol 1,2,3™ reagents are intended for use in the quantitative determination of cholesterol in the epidermal layer of the skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidermal layer of the skin, palmar surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Skin cholesterol levels were measured in 750 individuals (649 patients scheduled for coronary angiography and 101 age and gender matched controls). The patients were mostly Caucasian. For the 649 case patients who underwent coronary angiography, three coronary arteries (LAD, LCX and RCA) were scored as having no stenosis, up to 50% stenosis and greater than 50% stenosis.
The risk of significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel) increased as skin cholesterol levels increased in subjects with HDL levels less than 41 mg/dL. In subjects with HDL levels greater than 41 mg/dL the risk of multi-vessel disease was highest in the middle skin cholesterol tertile. The prevalence of significant multi-vessel coronary artery disease for angiography patients in this study was 36.5% (237/649).
The logistic regression analysis of skin cholesterol and HDL levels as risks factors for significant multi-vessel coronary artery disease showed that the skin cholesterol had statistically significant contribution (p=0.01) to the risk of significant multi-vessel disease even after adjusting for HDL cholesterol. The area under receiver operating characteristics curve for the skin cholesterol was 0.56 with 95% confidence interval of 0.52-0.61.
The probability to have prior myocardial infarction (MI) increased as skin cholesterol in individuals with low HDL levels. In subjects with HDL levels >41 mg/dL, history of MI was lowest in the first skin cholesterol tertile and highest in second tertile. The prevalence of history of MI for angiography patients in this study was 34.7% (225/649).
The angiography patients with low skin cholesterol (50 mg/dL) had the highest probability of being without disease (no stenosis at any three arteries). Conversely, the patients with high skin cholesterol (>135) and low HDL (
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.
0
JUN 2 4 2002
IMI - International Medical Innovations Inc., Section 510(k) Notification Cholesterol 1,2,3TM
Summary of Safety & Effectiveness Cholesterol 1,2,3TM
1.0 Submitted By:
Thomas M. Tsakeris Devices & Diagnostics Consulting Group, Inc. 16809 Briardale Road Rockville, MD 20855 Phone: 301-330-2076 Fax: 301-330-2568 E-mail: ttsak@erols.com
2.0 Date Submitted:
May 30, 2002
3.0 Device Name:
Cholesterol 1,2,3 TM
4.0 Predicate Devices:
| Predicate | Manufacturer | Docket
Number |
|-------------------------------------------------|----------------------------------|------------------|
| Synchron CX® Systems HDL Cholesterol
Reagent | Beckman Instruments, Inc. | K895851 |
| HDL Cholesterol Plus | Roche Diagnostics
Corporation | K000568 |
5.0 Description:
The Cholesterol 1,2,37M spectrophotometer in conjunction with the Cholesterol 1,2,3™ reagents are intended for use in the quantitative determination of cholesterol in the epidermal layer of the skin.
6.0 Intended Use and Indications for Use:
6.1 Intended Use:
Cholesterol 1,2,37% is an in vitro diagnostic test for the quantification of skin cholesterol. Cholesterol 1,2,3™ uses a detector reagent that reacts with skin cholesterol in proportion to the amount of cholesterol on the surface of the epidermis. An indicator reagent (horseradish peroxidase substrate) is added and color allowed to develop. Color intensity is proportional to the amount of bound skin cholesterol in the palmar surface of the skin. The color intensity (hue) can be measured objectively by use of a handheld reflectance spectrophotometer.
6.2 Indications for Use:
Skin cholesterol as measured by Cholesterol 1,2,37M can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being Test results, when considered in conjunction with clinical evaluation, blood considered. cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
1
IMI - International Medical Innovations Inc., Section 510(k) Notification Cholesterol 1,2,3 TM
7.0 Summary of Performance Data
Skin cholesterol levels were measured in 750 individuals (649 patients scheduled for coronary angiography and 101 age and gender matched controls). The patients were mostly Caucasian. For the 649 case patients who underwent coronary angiography, three coronary arteries (LAD, LCX and RCA) were scored as having no stenosis, up to 50% stenosis and greater than 50% stenosis.
As shown in Figure 1 and Table 1, the risk of significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel) increased as skin cholesterol levels increased in subjects with HDL levels less than 41 mg/dL. In subjects with HDL levels greater than 41 mg/dL the risk of multi-vessel disease was highest in the middle skin cholesterol tertile. The prevalence of significant multi-vessel coronary artery disease for angiography patients in this study was 36.5% (237/649).
Figure 1. Relative Risks of Significant Multi-Vessel Coronary Artery Disease (>50% stenosis in >1 vessel} According to Skin Cholesterol Tertile and HDL Range (the risk of significant multivessel coronary artery disease for subjects with HDL 135). The y-axis represents the relative risk, ranging from 0 to 1.4. There are three lines on the graph, representing HDL >50, HDL 41-50, and HDL 135 | Average Relative
Risk for
HDL Group |
| >50 | 0.53
(0.29; 0.85)
(12/56) | 0.78
(0.48; 1.12)
(17/54) | 0.58
(0.27; 1.01)
(8/34) | 0.63
(0.47; 0.83)
(37/144) |
| 41-50 | 0.67
(0.40; 1.01)
(15/55) | 1.15
(0.78; 1.53)
(21/45) | 0.99
(0.67; 1.33)
(22/55) | 0.92
(0.74; 1.12)
(58/155) |
| 41 mg/dL, history of MI was lowest in the first skin cholesterol tertile and highest in second tertile. The prevalence of history of MI for angiography patients in this study was 34.7% (225/649).
3
Figure 2. Relative Risks of Prior Myocardial Infarction (MI) According to Skin Cholesterol tertile and HDL range (the risk of prior MI for subjects with HDL50, HDL 41-50, and HDL 50 is lower than the relative risk of HDL 41-50 and HDL 135 | Average Risk for
HDL Group |
| >50 | 0.24
(0.09; 0.49)
(6/56) | 0.62
(0.37; 0.93)
(15/54) | 0.39
(0.15; 0.78)
(6/34) | 0.42
(0.28; 0.59)
(27/144) |
| 41-50 | 0.45
(0.23; 0.74)
(11/55) | 0.80
(0.49; 1.15)
(16/45) | 0.61
(0.36; 0.92)
(15/55) | 0.61
(0.46; 0.78)
(42/155) |
| 50 mg/dL) had the highest probability of being without disease (no stenosis at any three arteries). Conversely, the patients with high skin cholesterol (>135) and low HDL (135). The y-axis represents the percent without significant disease, ranging from 0 to 50. The graph shows three lines representing HDL levels: HDL >50, HDL 41-50, and HDL 135 | Average Risk for
HDL Group | | |
| >50 | 37.5%
(21/56)
(24.9%; 51.5%) | 38.9%
(21/54)
(25.9%; 53.1%) | 44.1%
(15/34)
(27.2%; 62.1%) | 39.6%
(57/144)
(31.5%; 48.1%) | | |
| | 41-50 | 30.9%
(17/55)
(19.1%; 44.8%) | 20.0%
(9/45)
(9.6%; 34.6%) | | 21.8%
(12/55)
(11.8%; 35.0%) | 24.5%
(38/155)
(18.0%; 32.1%) |
| | | 19.3%
(21/109)
(12.3%; 27.9%) | | 20.3%
(24/118)
(13.5%; 28.7%) | |
| Average Risk
for SC Group | | | 26.9%
(59/220)
(21.1%; 33.2%) | 24.9%
(54/217)
(19.3%; 31.2%) | 18.9%
(40/212)
(13.8%; 24.8%) | |
5
IMI - International Medical Innovations Inc., Section 510(k) Notification Cholesterol 1,2,3 M
As shown in table 4, data of this study demonstrated that there is no correlation of skin cholesterol with HDL (coefficient of correlation = - 0.06 with 95% confidence interval (-0.15; 0.02)).
| Skin Cholesterol (SC) Level (hue angle) | ||||
|---|---|---|---|---|
| HDL | ||||
| Level | ||||
| (mg/dL) | 135 | |||
| >50 | 8.6% | |||
| 56 | 8.3% | |||
| 54 | 5.2% | |||
| 34 | 22.2% | |||
| 144 | ||||
| 41-50 | 8.5% | |||
| 55 | 6.9% | |||
| 45 | 8.5% | |||
| 55 | 23.9% | |||
| 155 | ||||
| 145". The y-axis represents the number of subjects. For example, in the 86-95 range, there are approximately 21 Caucasian subjects and 25 African American subjects. |
Figure 4. Distribution of Skin Cholesterol by Race
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
7
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
JUN 2 4 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
International Medical Innovation, Inc. c/o Thomas M. Tsakeris President Devices & Diagnostics Consulting Group, Inc. 16809 Briardale Road Rockville, MD 20855
Re: K014018
Trade/Device Name: Cholesterol 1,2,3™ Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: I, reserved Product Code: LBS Dated: May 31, 2002 Received: May 31, 2002
Dear Mr. Tsakeris:
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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in screening the general population for coronary artery disease or for use as a substitute for blood cholesterol tests or a substitute for other risk factors identified for coronary artery disease have not been established.
8
Page 2 - Mr. Thomas M. Tsakeris
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
510(k) Number (if known): K014018
Device Name: Cholesterol 1,2,3TM
Intended Use Statement
Cholesterol 1,2,37M is an in vitro diagnostic test for the quantification of skin cholesterol. Cholesterol 1.2.37M uses a detector reagent that reacts with skin cholesterol in proportion to the amount of cholesterol on the surface of the epidermis. An indicator reagent (horseradish peroxidase substrate) is added and color allowed to develop. Color intensity is proportional to the amount of bound skin cholesterol in the palmar surface of the skin. The color intensity (hue) can be measured objectively by use of a handheld reflectance spectrophotometer.
Indications For Use Statement
Skin cholesterol as measured by Cholesterol 1,2,37M can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number: K014018
For Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
A. Butner
6124/02
(Division Sign-Off) Division of Clinical Laboratory Devices K 2000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 510(k) Number.