[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1055]

[Page 194-195]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--
Table of Contents
 
                Subpart B_Clinical Chemistry Test Systems
 
Sec. 862.1055  Newborn screening test system for amino acids, free
carnitine, and acylcarnitines using tandem mass spectrometry.

    (a) 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

[[Page 195]]

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.
    (b) 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 
Sec. 862.1(d) for the availability of this guidance document.

[69 FR 68255, Nov. 24, 2004]