Newborn Screening Test System

Published On -

I3CGlobal FDA 510k, IVDR

FDA 510K for Newborn Screening Test System for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry

The Newborn Screening Test for amino acids, free carnitine, and acylcarnitines using Tandem Mass Spectrometry (MS/MS) is a highly sensitive and efficient method for screening metabolic disorders in newborns. This test is used to identify a variety of inborn errors of metabolism (IEMs), many of which can be life-threatening if not diagnosed and treated early.

Intended Use of Newborn Screening Test System for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry

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

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Newborn Screening Test System 
REQUEST 510K QUOTE
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FDA 510K for Device Code and Regulation Number

S. No Product Code Device Regulation Description Regulation Number Class

1

NQL

 System, Test, Amino Acids, Free Carnitines and Acylcarnitines Tandem Mass Spectrometry Newborn Screening Test System for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.

862.1055

2

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

Intended Use:

It is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analysis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Device Description:

It is designed for newborn screening using dried blood spots. The kit helps measure a variety of biomarkers in newborns, including amino acids, succinyl acetone, free carnitine, acylcarnitine, nucleosides, and lysophospholipids. This testing is done using tandem mass spectrometry (MSMS) and helps evaluate metabolic disorders by profiling these analytes. The relationships between these analytes can offer valuable insights into the newborn’s metabolic health.

Performance Testing (Analytical) for Newborn Screening Test System for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry

  • Precision/Repeatability
  • Reproducibility
  • Linearity/assay reportable range
  • Analytical Specificity/Cross-Reactivity
  • Interference

Clinical Testing:

No Guidance available for 510k submission

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