FDA product code · Clinical chemistry

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

Name: FDA decisions, review times, recalls and adverse event reports for product code NQL
Creator: 510(k) Report

NQLClass II21 CFR 862.1055510(k) required5 decisions since 20042 recalls

5 FDA decisions since 2004. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K093916, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of NQL at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NQL

1in 2020

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQL

Too few NQL 510(k)s in any year since 2007 to give a median.

Recalls per year · NQL

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NQL

1in 2025

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code NQL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	1	—	0	0
2010	1	—	0	0
2011	0	—	0	0
2012	0	—	1	1
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	0	—	0	0
2020	1	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	1
2026	0	—	0	—

FIG. 1 — NQL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NQL? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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

Which predicates do NQL devices cite most?

Which NQL devices have the deepest lineage?

What has FDA decided in NQL lately?

What has been recalled in NQL lately?