# P010033: Quanttferon-TB Gold and TB Gold-in-the-Tube

- Pathway: PMA
- Applicant: Qiagen
- Decided: Nov 28, 2001 after 180 days
- Product code: NCD (Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis)
- Device class: 3
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 2, 2016 · Class II · Z-1230-2016: Potential for obtaining a false positive result due to the possibility of endotoxin presence.
- Sep 27, 2012 · Class II · Z-0889-2013: Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
- Sep 27, 2012 · Class II · Z-0888-2013: Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.

Source page: https://510kreport.com/device/P010033
Methodology: https://510kreport.com/methodology