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K Number
K993377
Device Name
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
Manufacturer
POLYMER TECHNOLOGY SYSTEMS, INC.
Date Cleared
2000-01-13

(107 days)

Product Code
NAQ
Regulation Number
862.1175
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

Device Description

Not Found

AI/ML Overview

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.

§ 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.