MTM BIOSCANNER K TEST STRIPS, CAT # BSA610

• K Number: K983860
• Device Name: MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
• Manufacturer: POLYMER TECHNOLOGY SYSTEMS, INC.
• Date Cleared: 1999-12-27 ( 420 days)
• Product Code: JMK
• Regulation Number: 862.1380
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

MTM BioScanner K Test Strips are intended for the quantitative measurement of ketones in capillary whole blood in physicians office labs and at the bedside by professionals and at home by lay users.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "MTM BioScanner K Test Strips." It does not include a study or information about acceptance criteria and device performance.

Regulation Number and Section

§ 862.1380 Hydroxybutyric dehydrogenase test system.

(a)
Identification. A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.(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 the limitations in § 862.9.