NQL

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

Product code

NQL

Device name

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

Device class

Class 2

21 CFR

21 CFR 862.1055

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.

Definition text from the FDA device classification database (U.S. federal government work, public domain).