G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

• K Number: K024006
• Device Name: G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
• Manufacturer: POINTE SCIENTIFIC, INC.
• Date Cleared: 2003-03-31 ( 117 days)
• Product Code: JBF
• Regulation Number: 864.7360
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter and an Indications for Use statement for a medical device. It does not contain information about acceptance criteria, study details, or device performance as requested in the prompt. Therefore, I cannot provide the requested information based on this input.

Regulation Number and Section

§ 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.

(a)
Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.(b)
Classification. Class II (performance standards).