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U.S. Department of Health and Human Services

Medical Devices

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Access® Hybritech p2PSA on the Access Immunoassay Systems – P090026

Photo of Hybritech p2PSA Test

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: Access® Hybritech p2PSA on the Access Immunoassay Systems
PMA Applicant: Beckman Coulter, Inc
Address: 1000 Lake Hazeltine Drive, Chaska, MN 55318
Approval Date: June 14, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090026a.pdf

What is it? The Access® Hybritech p2PSA on the Access Immunoassay Systems is an automated laboratory test that measures how much [-2]proPSA a man has in his blood. The test calculates the probability of having cancer using the [-2]proPSA measurement in conjunction with the total PSA and free PSA measurements from the same blood sample. The [-2]proPSA is a form of free PSA and is associated with prostate cancer because higher levels are found in the blood and tissue of prostate cancer patients.

How does it work?

  • The doctor takes a blood sample from the patient.
  • The red blood cells in the sample are allowed to form a clot and the clear fluid (serum) is separated and used for the test.
  • With special chemicals, light will be produced and measured by the automated instrument (the Access Immunoassay System). The amount of light produced shows the amount of [-2]proPSA in the sample.
  • The test automatically combines the [-2]proPSA measurement with total PSA and free PSA measurements from the same blood sample in a mathematical formula to calculate a Prostate Health Index (phi). The index gives the probability of cancer.
  • The pathologist reviews the results and reports the findings to the ordering doctor.

When is it used? For men 50 years and older with a total PSA value between 4 ng/mL and 10 ng/mL and a digital rectal exam with no suspicion of cancer.

What will it accomplish? This test will help determine if a man has cancer with a total PSA value between 4 ng/mL and 10 ng/mL and whether he needs a biopsy. Thus, this test may help reduce the number of unnecessary biopsies in men who have a total PSA value between 4 ng/mL and 10 ng/mL, but are unlikely to have cancer.

When should it not be used? There are no known contraindications.

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

Other Resources: