NQL · System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Clinical Chemistry · 21 CFR 862.1055 · Class 2
Overview
| Product Code | NQL |
|---|---|
| Device Name | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Regulation | 21 CFR 862.1055 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry is a device that consists of stable isotope internal standards, control materials, extraction solutions, flow solvents, instrumentation, software packages, and other reagents and materials. The device is intended for the measurement and evaluation of amino acids, free carnitine, and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of amino acids, free carnitine, and acylcarnitines and their relationship with each other provides analyte concentration profiles that may aid in screening newborns for one or more inborn errors of amino acid, free carnitine, and acyl-carnitine metabolism.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.” See § 862.1(d) for the availability of this guidance document.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | Feb 7, 2020 | SESE |
| K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | Sep 4, 2018 | SESE |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | Perkinelmer, Inc. | Aug 23, 2010 | SESE |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | Perkinelmer, Inc. | Jul 9, 2009 | SESE |
| DEN040002 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 | Perkinelmer Life Sciences, Inc. | Aug 24, 2004 | DENG |
Top Applicants
- Perkinelmer, Inc. — 3 clearances
- Perkinelmer Life Sciences, Inc. — 1 clearance
- Wallac Oy, Subsidiary of Perkinelmer, Inc. — 1 clearance
