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  1. Device Approvals, Denials and Clearances

Abbott RealTime CMV Assay - P160044

Abbott RealTime CMV Assay - P160044

Image of Abbott RealTime CMV Assay - P160044

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: RealTime CMV Assay
PMA Applicant: Abbott Molecular, Inc.
Address: 1300 E. Touhy Ave, Des Plaines, IL 60018
Approval Date: 5/18/2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160044A.pdf

What is it? The RealTime CMV Assay is a laboratory test designed to measure the amount of cytomegalovirus (CMV) DNA that may be present in the blood of a patient who has undergone a bone marrow transplant. CMV is a human viral pathogen, and approximately half of all bone marrow transplant patients develop the virus, and may require anti-CMV therapy. This test is used along with the Abbott m2000sp RealTime system and the Abbott m2000rt instrument for detection of the CMV virus. The results from the test must be interpreted within the context of all other relevant clinical and laboratory findings.

How does it work? A sample of a patient's blood is obtained from a vein and sent to a clinical laboratory. Nucleic Acid (DNA) is automatically separated from the blood using the Abbott m2000sp system. The separated DNA is mixed with the assay reagents and the resulting mixture is placed into the Abbott m2000rt instrument. The RealTime systems calculates the amount of CMV DNA in the patient's blood based on the amount of produced light measured by the analyzer after the completion of the reaction.

Measurement of the amount of CMV DNA in the blood together with clinical presentation and other laboratory findings is used by health care providers to determine if a bone marrow transplant patient is actively infected with CMV and if treatment is necessary, to subsequently to determine that an individual has responded to treatment.

When is it used? This test is used together with other laboratory results and clinical information to determine whether a bone marrow transplant recipient has active CMV infection and as an aid in the management of bone marrow transplant patients who are undergoing anti-CMV therapy.

What will it accomplish? CMV infection can be very serious in patients who have undergone bone marrow transplantation; measuring the amount of CMV in blood is important since treatment, when needed, is essential for care of the patient.

When should it not be used? This lab test should not be used if it is not ordered by a health care provider.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.