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Consumer Information on: Abbott Laboratories ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls - P120008

Wed, 12/05/2012 - 12:00am
U.S. Food & Drug Administration

Image of ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls
PMA Applicant: Abbott Laboratories
Address: Dept. 09V6 AP5-2N, 100 Abbott Park Road, Abbott Park, IL 60064-6070
Approval Date: November 28, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/
p120008a.pdf

What is it? The ARCHITECT AFP Assay is an automated laboratory molecular immunoassay test that measures how much alpha-fetoprotein (AFP) is in serum or plasma (blood products) or amniotic fluid. The test has two unique uses: 1) to aid in the management of patients with a certain form of cancer of the testis (nonseminomatous) and 2) to aid in the detection of openings of the brain or spinal cord (open neural tube defects) between weeks 15 and 21 of pregnancy.

How does it work?

  • The doctor takes a sample of the patient’s blood or amniotic fluid and sends the sample to a laboratory for testing.
  • At the testing laboratory, a trained medical professional prepares the sample and measures AFP in the sample using the ARCHITECT AFP test.
  • The ACRHITECT AFP Calibrators and ARCHITECT AFP Controls can be used with the ACHITECT AFP Assay to indicate that the assay is performing properly.
  • With special chemicals, light will be produced and measured by the automated instrument. The amount of light produced shows the amount of AFP in the sample.
  • Cancer monitoring: AFP levels that remain elevated or rise following surgery can indicate the cancer is still present or is getting worse.
  • Prenatal testing: The results from this test, when used in conjunction with ultrasound or an x-ray of the amniotic sac (amniography), can help a physician to detect open neural tube defects. Usually high levels of AFP in the amniotic fluid can indicate the presence of a neural tube defect in the fetus.

When is it used? This test is used in the men who have already been diagnosed with nonseminomatous testicular cancer and women who are between 15 and 21 weeks pregnant.

What will it accomplish? This test helps to determine if a testicular cancer is progressing or to help determine if a fetus has a particular birth defect.

When should it not be used? No known contraindications.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Other Resources:

 

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