# System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
> **Product code: NQL** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1055
## Classification
- **FDA Product Code:** NQL
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1055
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQL)
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