CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30

• K Number: K973999
• Device Name: CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
• Manufacturer: DIAGNOSTIC CHEMICALS LTD.
• Date Cleared: 1998-03-11 ( 141 days)
• Product Code: CGS
• Regulation Number: 862.1215
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.

Device Description

Creatine Kinase-SL Assay, Catalogue Number 326-10, 326-30

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Creatine Kinase-SL Assay" and does not contain the detailed information required to describe acceptance criteria and associated study results. The letter confirms substantial equivalence to a predicate device but does not specify performance metrics, study designs, sample sizes, or ground truth methodologies.

Therefore, I cannot provide the requested information based on the given input.

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.