PMA P010033S047

Device

QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

Applicant

Qiagen

PMA number

P010033

Supplement

S047

Product code

NCD

Decision date

2021-12-13

Generic name

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

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.