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:  Alinity m HBV
PMA Applicant:  Abbott Molecular, Inc.
Address:  1300 E. Touhy Avenue; Des Plaines, IL 60018
Approval Date:   August 29, 2020
Approval Letter:  Approval Order

What is it? The Alinity m HBV is a laboratory test used to detect hepatitis B virus (HBV) DNA in a patient’s blood sample. The presence of HBV DNA means that the virus is replicating in the body and that the patient has an active hepatitis B viral infection.

How does it work? A sample of the patient’s blood is sent to a clinical laboratory. At the laboratory, the blood is inserted into the Alinity m Instrument, where it is mixed with test chemicals. The test works by real-time polymerase chain reaction (PCR), which increases the amount of HBV in the sample when HBV is present. The Allinty M system is then able to measure and report the amount of HBV in the patient’s blood.

When is it used? The Alinity m HBV is used to help manage patients with chronic HBV infection undergoing anti-viral therapy.

What will it accomplish? The tests helps doctors manage the treatment of patients who have chronic HBV infection.

When should it not be used?  This test should not be used to screen blood, blood products, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• PMA Database Entry