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The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the BioScanner. This system is intended to be used to assist the healthcare professional and individuals in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

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I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the MTM BioScanner HDL Test Strips, indicating that the device is substantially equivalent to a legally marketed predicate device.

It includes:

• Device Name: MTM BioScanner HDL Test Strips, Over the Counter (OTC) Use
• Intended Use: "The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the BioScanner. This system is intended to be used to assist the healthcare professional and individuals in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease."
• Regulatory Class: I reserved
• Product Code: NAQ
• 510(k) Number: K993377

However, it does not provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a detailed technical report or study summary.

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