PREVU POINT OF CARE SKIN STEROL TEST by PREMD, INC.

Skin cholesterol as measured by PREVU* POC 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.

Device Description

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AI/ML Overview

This document (K062092) is a 510(k) clearance letter from the FDA for the PREVU* POC Skin Sterol Test, indicating substantial equivalence to a legally marketed predicate device. It is important to note that this document does not contain information about specific acceptance criteria, study data proving the device meets those criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This often involves comparing device features, intended use, and performance characteristics (which would be provided by the manufacturer in their 510(k) submission). However, the clearance letter provided here is merely the FDA's decision, not the full submission with detailed internal study data.

Therefore,Based on the provided FDA 510(k) clearance letter for the PREVU* POC Skin Sterol Test (K062092), the following information cannot be extracted:

Table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. The letter acknowledges the device's substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in the manufacturer's submission.
Sample size used for the test set and the data provenance: This information is not included in the FDA clearance letter. The letter does not describe the studies conducted by the manufacturer, nor the characteristics of the data used in those studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the FDA clearance letter.
Adjudication method for the test set: This information is not provided in the FDA clearance letter.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: This information is not relevant to the clearance of a diagnostic test like the PREVU* POC Skin Sterol Test, which is not an AI-assisted diagnostic. Furthermore, the letter does not mention such a study.
If a standalone performance study was done: While a performance study would have been part of the manufacturer's 510(k) submission, the details of such a study (including whether it was a "standalone" algorithm performance study, which typically refers to AI/algorithm-only performance) are not included in this FDA clearance letter.
The type of ground truth used: This information is not provided in the FDA clearance letter.
The sample size for the training set: As with the test set, information about training data for any model used in the device is not present in this FDA clearance letter.
How the ground truth for the training set was established: This information is not provided in the FDA clearance letter.

In summary, the provided document is a regulatory clearance notice and does not contain the detailed technical or clinical study data that would address the requested points. The FDA's decision of substantial equivalence indicates that they reviewed the manufacturer's submitted data and determined it met the requirements for marketing, but the specifics of those data are not part of this public clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP

PreMD, Inc. C/O Thomas M. Tsakeris, President Devices and Diagnostics Consulting Group, Inc. 16809 Briardale Rd. Rockville, MD 20855

Re: K062092

Trade/Device Name: PREVU* POC Skin Sterol Test Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I, subject to 21 CFR 862.9(c)(4) Product Code: LBS Dated: August 18, 2006 Received: August 18, 2006

Dear Mr. Tsakeris:

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 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 In Vitro Diagnostic Device Evaluation and Safety 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.

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.

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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 described above is added to your labeling.

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 (CFR), Title 21, 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).

If you desire specific information about the application of other 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''(21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Carol Bensonfor

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Devices 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): K062092

Device Name: PREVU* Point of Care (POC) Skin Sterol Test

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Regulation Number and Section

§ 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.