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

- Device class: 2; regulation: 21 CFR 862.1055; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 1
- 2009: 1
- 2010: 1
- 2018: 1
- 2020: 1

## Most-cited predicates
- K093916: Neobase Non-Derivatized MSMS Kit Model 3040-001U (2010), cited by 1
- DEN040002: Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970 (2004), cited by 1
- K173568: NeoBase 2 Non-derivatized MSMS Kit (2018), cited by 1
- K083130: Neobase Non-Derivatized MSMS Kit, Model 3040 (2009), cited by 1

Source page: https://510kreport.com/product-code/NQL
Data by year (CSV): https://510kreport.com/product-code/NQL.csv