MTM BIOSCANNER C TEST STRIPS

• K Number: K990688
• Device Name: MTM BIOSCANNER C TEST STRIPS
• Manufacturer: POLYMER TECHNOLOGY SYSTEMS, INC.
• Date Cleared: 1999-06-24 ( 119 days)
• Product Code: CHH
• Regulation Number: 862.1175
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The MTM BioScanner C Test Strip is intended for the in-vitro-diagnostic quantitation of total Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the MTM BioScanner C Test Strips and the MTM BioScanner 1000 system. It does not contain a study describing acceptance criteria, device performance, or details of a validation study for an AI/ML device. Therefore, I cannot provide the requested information.

Regulation Number and Section

§ 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.