Identifiers
- 510(k) Number
- K172708 FDA 510(k)
- FDA Product Code
- QBX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3960 FDA 510(k)
- Regulation Number
- 866.3960 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The T2Bacteria Panel is a Direct Blood Bacterial Nucleic Acid Detection System used for the qualitative detection of bacterial species in human whole blood specimens. It is a T2 Magnetic Resonance (T2MR) test that identifies six specific bacteria: Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
The test is performed on the T2Dx Instrument using K2EDTA human whole blood specimens from patients with suspected bacteremia. It is supplied as an in vitro diagnostic device for use in clinical laboratory settings. The device has received FDA 510(k) clearance under product code QBX and regulation number 866.3960, and is classified as a Class II medical device in the Microbiology specialty.
Frequently asked questions
What is the T2Bacteria Panel used for?
The T2Bacteria Panel is used for the qualitative detection of bacterial species in human whole blood specimens from patients with suspected bacteremia, identifying six specific bacteria: Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
How is the T2Bacteria Panel supplied and what specimen type is required?
The T2Bacteria Panel is supplied as an in vitro diagnostic device for use in clinical laboratory settings and requires K2EDTA human whole blood specimens for testing on the T2Dx Instrument.
Is the T2Bacteria Panel a single-use or reusable test?
The T2Bacteria Panel is a single-use in vitro diagnostic test, as it is designed for one-time use on the T2Dx Instrument with individual patient specimens and is not intended for reuse.
What regulatory pathway was used for the T2Bacteria Panel and what is its classification?
The T2Bacteria Panel received FDA 510(k) clearance under product code QBX and regulation number 866.3960, and is classified as a Class II medical device in the Microbiology specialty.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: T2Bacteria® Panel (K233184) — FDA 510 (k) | Innolitics, PDF T2BACTERIA PANEL - euromed.ch, PDF February 8, 2024 T2 Biosystems, Inc. Rachel Gilbert Manager, Regulatory ..., PDF K233184 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172708 | Class II | Active |
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Manufacturer
- Manufacturer
- T2biosystems, Inc.
Sources (1)
- FDA 510(k) K172708 24 fields · synced Sep 21, 2026