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U.S. Department of Health and Human Services

Product Classification

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Device system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
Regulation Description Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
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.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNQL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1055
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry - Class II Special Controls Guidance Document
Third Party Review Not Third Party Eligible
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