System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
The tandem mass spectrometry test system for amino acids, free carnitines, and acylcarnitines is a clinical chemistry diagnostic device intended to measure and evaluate concentrations of these metabolites from newborn whole blood filter paper samples, providing analyte concentration profiles to aid in newborn screening for multiple metabolic disorders. It is classified as FDA Class 2 under regulation 862.1055 in the Clinical Chemistry specialty, requiring 510(k) premarket notification. Product code NQL is not eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NQL
- Device Class
- FDA class 2
- Regulation Number
- 862.1055
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Feb 07, 2020 | Substantially Equivalent | Perkinelmer, Inc. |
| K173568 | NeoBase 2 Non-derivatized MSMS Kit | Sep 04, 2018 | Substantially Equivalent | Wallac Oy, Subsidiary of Perkinelmer, Inc. |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | Aug 23, 2010 | Substantially Equivalent | Perkinelmer, Inc. |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | Jul 09, 2009 | Substantially Equivalent | Perkinelmer, Inc. |
| DEN040002 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 | Aug 24, 2004 | Unknown | Perkinelmer Life Sciences, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.