The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) 180-day supplement, which requested 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.
| Device | QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus |
| Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Applicant | QIAGEN |
| Date Received | 2021-03-26 |
| Decision Date | 2021-12-13 |
| PMA | P010033 |
| Supplement | S047 |
| Product Code | NCD |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN 19300 Germantown Road germantown, MD 20874 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010033 | | Original Filing |
| S048 |
2022-09-30 |
Real-time Process |
| S047 |
2021-03-26 |
Normal 180 Day Track |
| S046 |
2019-11-06 |
30-day Notice |
| S045 |
2019-04-15 |
Real-time Process |
| S044 |
2019-04-04 |
30-day Notice |
| S043 |
2019-02-15 |
30-day Notice |
| S042 |
2018-12-13 |
30-day Notice |
| S041 |
2018-09-25 |
Real-time Process |
| S040 |
2018-09-07 |
30-day Notice |
| S039 |
2018-02-28 |
30-day Notice |
| S038 |
2018-01-26 |
30-day Notice |
| S037 |
2018-01-11 |
135 Review Track For 30-day Notice |
| S036 |
2017-11-13 |
30-day Notice |
| S035 |
2017-10-31 |
30-day Notice |
| S034 |
2017-05-24 |
30-day Notice |
| S033 |
2017-04-12 |
30-day Notice |
| S032 |
2017-02-06 |
30-day Notice |
| S031 |
2016-12-09 |
Normal 180 Day Track |
| S030 |
2016-07-28 |
30-day Notice |
| S029 |
2016-07-21 |
30-day Notice |
| S028 |
2016-03-25 |
30-day Notice |
| S027 | | |
| S026 |
2014-11-10 |
30-day Notice |
| S025 |
2014-10-24 |
Normal 180 Day Track No User Fee |
| S024 |
2014-04-23 |
30-day Notice |
| S023 |
2013-12-23 |
30-day Notice |
| S022 | | |
| S021 | | |
| S020 |
2012-04-11 |
Normal 180 Day Track |
| S019 |
2011-08-04 |
Special (immediate Track) |
| S018 |
2011-02-23 |
30-day Notice |
| S017 |
2010-08-30 |
Special (immediate Track) |
| S016 |
2010-05-20 |
135 Review Track For 30-day Notice |
| S015 |
2009-06-10 |
135 Review Track For 30-day Notice |
| S014 |
2009-06-02 |
135 Review Track For 30-day Notice |
| S013 |
2008-06-10 |
Real-time Process |
| S012 |
2007-03-16 |
Normal 180 Day Track No User Fee |
| S011 |
2006-06-01 |
Normal 180 Day Track |
| S010 |
2006-02-14 |
Special (immediate Track) |
| S009 |
2005-11-22 |
Normal 180 Day Track No User Fee |
| S008 | | |
| S007 |
2004-01-14 |
30-day Notice |
| S006 |
2003-12-04 |
Normal 180 Day Track |
| S005 |
2003-04-18 |
30-day Notice |
| S004 |
2003-02-28 |
Real-time Process |
| S003 |
2003-02-20 |
Special (immediate Track) |
| S002 |
2002-12-02 |
30-day Notice |
| S001 |
2002-10-07 |
30-day Notice |
NIH GUDID Devices