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K Number
K062026
Device Name
VAP-NT CHOLESTEROL TEST
Manufacturer
ATHEROTECH, INC.
Date Cleared
2007-03-06

(231 days)

Product Code
CHH,LBS,MRR
Regulation Number
862.1175
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

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.

§ 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.