NQL — System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Class II
FDA product code NQL covers "System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry", a Class II medical device regulated under 21 CFR 862.1055. Submissions are reviewed by the Clinical Chemistry panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NQL
- Device Class
- Class II
- Regulation Number
- 862.1055
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K193103 | perkinelmer | NeoBase 2 Non-derivatized MSMS Kit | February 7, 2020 |
| K173568 | wallac oy, subsidiary of perkinelmer | NeoBase 2 Non-derivatized MSMS Kit | September 4, 2018 |
| K093916 | perkinelmer | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | August 23, 2010 |
| K083130 | perkinelmer | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | July 9, 2009 |
| DEN040002 | perkinelmer life sciences | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-89 | August 24, 2004 |