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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantQIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS047
Date Received03/26/2021
Decision Date12/13/2021
Product Code NCD 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following changes to the QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus device packge inserts:1) Removal of the following language from the Warnings and Precautions section from the QuantiFERON®-TB Gold device packge insert:The performance of the USA format of the QFT test has not been extensively evaluated with specimens from the following groups of individuals: I. Individuals who have impaired or altered immune functions, such as those who have HIV infection or AIDS, those who have transplantation managed with immunosuppressive treatment or others who receive immunosuppressive drugs (e.g., corticosteroids, methotrexate, azathioprine, cancer chemotherapy), those who have other clinical conditions, such as diabetes, silicosis, chronic renal failure, and hematological disorders (e.g., leukemia and lymphomas), or those with other specific malignancies (e.g., carcinoma of the head or neck and lung). II. Individuals younger than age 17 years III. Pregnant women 2.Removal of the following language from the Limitations section from the QuantiFERON®-TB Gold Plus device packge insert:The performance of the USA format of the QFT-Plus test has not been extensively evaluated with specimens from the following groups of individuals: -- Individuals who have impaired or altered immune functions, such as those who have HIV infection or AIDS, those who have transplantation managed with immunosuppressive treatment or others who receive immunosuppressive drugs (e.g., corticosteroids, methotrexate, azathioprine, cancer chemotherapy), those who have other clinical conditions, such as diabetes, silicosis, chronic renal failure, and hematological disorders (e.g., leukemia and lymphomas), or those with other specific malignancies (e.g., carcinoma of the head or neck and lung). -- Individuals younger than age 17 years • Pregnant women 3. Addition of the following language to the Summary and Explanation of the Test section of the device package insert of both the QuantiFERON®-TB Gold and QuantiFERON®-TB Gold Plus:Diagnostic testing for Mycobacterium tuberculosis using Interferon Gamma Release Assays should follow applicable published guidelines. QFT has been studied in adults and children identified at higher risk for TB infection, including individuals recently exposure to persons with active tuberculosis, persons living with HIV or otherwise immunocompromised, immigrants from high-burden countries, and residents or employees of high-risk congregate settings. (See WARNINGS and PRECAUTIONS below regarding use in co-morbid conditions that may affect immune function below.) (34-71)Links to the most recent American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children, as well as to other information regarding diagnostic testing for tuberculosis, are available at https://www.cdc.gov/tb/publications/guidelines/testing.htm.
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