# K233184: T2Bacteria® Panel

- Pathway: 510(k) (Traditional)
- Applicant: T2biosystems, Inc.
- Decided: Feb 8, 2024 after 133 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: 2 generations back to DEN140019 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172708: T2Bacteria Panel, T2biosystems, Inc. (2018) Summary page 4.

## 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 six species of bacteria: Acinetobacter baumannii, 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/K233184
Methodology: https://510kreport.com/methodology