FDA product code NQL: System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
NQL is the FDA product code for system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry. It is a Class II device, regulated under 21 CFR 862.1055 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under NQL, from 2 different applicants. The average 510(k) review took 220 days (median 252). 1 De Novo request was granted under it. FDA has posted 3 recalls for NQL devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Device class | Class II |
| Regulation | 21 CFR 862.1055 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for NQL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 288 |
| 2020 | 1 | 91 |
Compare with all 510(k) review times · Search every NQL clearance
Top NQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perkinelmer, Inc. | 3 | 2020-02-07 |
| Wallac Oy, Subsidiary of Perkinelmer, Inc. | 1 | 2018-09-04 |
Most recent NQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193103 | Perkinelmer, Inc. | NeoBase 2 Non-derivatized MSMS Kit | 2020-02-07 | 91 |
| K173568 | Wallac Oy, Subsidiary of Perkinelmer, Inc. | NeoBase 2 Non-derivatized MSMS Kit | 2018-09-04 | 288 |
| K093916 | Perkinelmer, Inc. | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | 2010-08-23 | 244 |
| K083130 | Perkinelmer, Inc. | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | 2009-07-09 | 259 |
Recalls for NQL devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code NQL?
NQL is the FDA product code for system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry. It is a Class II device, regulated under 21 CFR 862.1055 and reviewed by the Clinical Chemistry panel.
What device class is NQL?
Class II, regulation 21 CFR 862.1055. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQL?
Across 4 cleared submissions the average was 220 days from receipt to decision (median 252).
Which companies have the most NQL clearances?
Perkinelmer, Inc. (3); Wallac Oy, Subsidiary of Perkinelmer, Inc. (1).
Have NQL devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2017-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NQL
- Run a recall and safety report across every NQL manufacturer
- Watch product code NQL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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