ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

• K Number: K991498
• Device Name: ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
• Manufacturer: NEOMETRICS, INC.
• Date Cleared: 1999-06-16 ( 48 days)
• Product Code: JIA
• Regulation Number: 862.1310
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a clearance letter from the FDA for a medical device (Accuwell™ Total Galactose kits) and an "Indications For Use" statement. It does not contain any scientific study data or performance metrics.

Regulation Number and Section

§ 862.1310 Galactose test system.

(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.