This is a brief overview of information related to FDA’s clearance to market this product. See the links below to the 510(k) Summary and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s clearance.
Product Name: NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970
Manufacturer: PerkinElmer Life and Analytical Sciences, Inc.
Address: 3895 Eastern Road, Norton OH 44203
Clearance Date: August 24, 2004
Clearance Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k031878.pdf
What is it? The NeoGram Kit is a lab test used by a doctor to measure the levels of amino acids and substances called free carnitine and acylcarnitines in newborn babies. Inherited abnormalities of amino acids, free carnitine and acylcarnitines may cause developmental delay, seizures, mental retardation and death, which may show up in the first weeks, months or years of life.
Early detection and treatment of these kinds of disorders with dietary, medical and social interventions frequently leads to improved long term outcome and quality of life.
While small amounts of these substances are found in everyone, abnormally high amounts, or abnormal patterns, may indicate different disease states called inborn errors of metabolism such as:
- phenylketonuria (PKU),
- maple syrup urine disease (MSUD),
- medium chain Acyl-CoA dehydrogenase deficiency (MCAD),
- isovaleric acidemia,
- homocystinuria, and
- hereditary tyrosinemia.
Testing for these kinds of disorders may be required by your state’s newborn screening program.
How does it work? A doctor orders the newborn screening panel determined by your state health department. If your state health department requires testing for these kinds of disorders, then a portion of the sample is tested for amino acids, free carnitine and acylcarnitines.
- A sample of the baby’s blood is collected by a heel prick and taken to the lab.
- The lab performs the NeoGram test.
- The lab result for the NeoGram test is sent to the state health department and the doctor.
- The doctor uses the NeoGram test results, clinical evaluation and other lab tests to determine the baby’s risk of having these kinds of disorders
When is it used? The NeoGram Kit is used to test newborn babies in states where screening for these disorders is required.
You should discuss these test results with your child's doctor at your child's first doctor appointments (usually at 3 days old, 2 weeks old and 4 to 8 weeks old). This test is not a substitute for your child's regularly scheduled health care visits.
What will it accomplish? The NeoGram Kit may help the doctor determine if a baby has risk for one or more of these kinds of disorders (eg: PKU, MSUD, etc.)
When should it not be used? The NeoGram Kit should not be used:
- As the only test to determine if a baby might be at risk for these kinds of disorders. It should only be used along with clinical evaluation and other tests.
- On patients other than newborn babies.