DeviceClearance

Product code NQL— Clinical Chemistry

NeoBase 2 Non-derivatized MSMS Kit

Classification name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Device class
Class 2
Regulation
21 CFR 862.1055
Advisory panel
Clinical Chemistry
Total cleared
5
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NQL under 21 CFR 862.1055, via openFDA

Market context for product code NQL

FDA has cleared 5 devices under product code NQL between 2004 and 2020, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NQL

Recent clearances under product code NQL

Data sourced from openFDA. This site is unofficial and independent of the FDA.