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K Number
K981493
Device Name
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
Manufacturer
POLYMER TECHNOLOGY SYSTEMS, INC.
Date Cleared
1998-07-22

(86 days)

Product Code
CHH
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 C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the MTM Bioscanner C Test Strips. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter primarily covers:

  • Confirmation of substantial equivalence to a predicate device.
  • Regulatory classification (Class I).
  • Applicability of general controls provisions of the Act.
  • Instructions regarding CLIA complexity categorization.
  • Contact information for labeling, promotion, and general responsibilities.
  • The intended use of the device: "in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease."

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study details as they are not present in the provided text.

§ 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.