(231 days)
The VAP-NT cholesterol test is a device intended to measure total cholesterol, and its component lipoprotein fractions from VLDL to HDL, in fasting serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Not Found
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to Atherotech, Inc. regarding their VAP-NT Cholesterol Test. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, this letter does not contain the detailed study information you are asking for, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, or data provenance.
- Information about experts used for ground truth (number, qualifications, adjudication method).
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance.
- Specifics about the type of ground truth used or how it was established for training or testing.
The letter primarily confirms the FDA's decision on substantial equivalence and outlines regulatory obligations, and includes an "Indications for Use Statement." The actual performance data and study details that would support an acceptance criteria description are not present in this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca K. Pine Atherotech, Inc. 15217 Springdale Street Huntington Beach, CA 92649
MAR 0 6 2007
Re: K062026 Trade/Device Name: VAP-NT Cholesterol Test Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system. Regulatory Class: Class I, meets the limitation to exemption (21 CFR 862.9(c)(4)) Product Code: CHH, MRR, LBS Dated: February 26, 2007 Received: February 27, 2007
Dear Ms. Pine:
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) 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 (see 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., 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 Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K Ole 2-D2
Device Name: VAP-NT Cholesterol Test
Indications for Use:
The VAP-NT cholesterol test is a device intended to measure total cholesterol, and its component lipoprotein fractions from VLDL to HDL, in fasting serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
X
Prescription Use and here is the markdown representation of the text:X
Prescription Use
§ 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.