ALPHA DX SYSTEM

• K Number: K010562
• Device Name: ALPHA DX SYSTEM
• Manufacturer: FIRST MEDICAL, INC.
• Date Cleared: 2001-03-13 ( 15 days)
• Product Code: MMI , DDR , GKF , JHX , KHO
• Regulation Number: 862.1215
• Type: Special
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.