# K172708: T2Bacteria Panel

- Pathway: 510(k) (Traditional)
- Applicant: T2biosystems, Inc.
- Decided: May 24, 2018 after 258 days
- Product code: QBX (Direct Blood Bacterial Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN140019 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140019: T2CANDIDA and T2DX Instrument, T2biosystems, Inc. (2014) Summary page 5.

## Most influential descendants
- K233184: T2Bacteria® Panel (2024), 0 descendants of its own

## Indications for use
The T2Bacteria Panel run on the T2Dx Instrument is a qualitative T2 magnetic resonance (T2MR) test for the direct detection of bacterial species in K2EDTA human whole blood specimens from patients with suspected bacteremia. The T2Bacteria Panel identifies five species of bacteria: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus. The T2Bacteria Panel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory data. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification, and for organisms not detected by the T2Bacteria Panel. Results from the T2Bacteria Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions in patients with suspected bacteremia.

Source page: https://510kreport.com/device/K172708
Methodology: https://510kreport.com/methodology