510(k) · Cleared
ClearedT2 Biothreat Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T2biosystems, Inc. · QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Cleared on Sep 15, 2023 as substantially equivalent to K170883 (Biofire Defense, LLC, 2017) after a 130-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Sep 15, 2023
- Review
- 130 days
- Class
- Class II
- Product code
- QVR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K170883 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK170883 FilmArray NGDS Warrior PanelBiofire Defense, LLC · 2017 · Recalled
- This deviceK231336 T2 Biothreat PanelT2biosystems, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K170883 | FilmArray NGDS Warrior Panel | Biofire Defense, LLC | 2017 | 3 |
| 0 (this device) | K231336 | T2 Biothreat Panel | T2biosystems, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QVR device
- #1 K261362 Xpert Hemorrhagic Feverscore 13.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170883 | FilmArray NGDS Warrior PanelSummary page 18…ate Device Predicate Device(s): K231336 K170883 Device Trade Name T2Biotreat Panel FilmArray NGDS Warrior Panel General Device Ch… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K170883.
How does its category compare?
All QVR devicesQVR Multiplex Nucleic Acid Detection System For Biothreat Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVR
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVR
Too few QVR 510(k)s in any year since 2007 to give a median.
Recalls per year · QVR
No recall names QVR since 2007.
Adverse event reports per year · QVR
No MAUDE report names QVR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The T2Biothreat Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the T2Dx Instrument. The T2Biothreat Panel detects nucleic acids from the following organisms directly from K2EDTA whole blood samples: 1. Bacillus anthracis (plasmids pXO1 and pXO2) 2. Francisella tularensis 3. Burkholderia spp. (B. mallei/B. pseudomallei) 4. Yersinia pestis 5. Rickettsia prowazekii The T2Biothreat Panel will not…
Read the full statement (373 words)
The T2Biothreat Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the T2Dx Instrument. The T2Biothreat Panel detects nucleic acids from the following organisms directly from K2EDTA whole blood samples:
1. Bacillus anthracis (plasmids pXO1 and pXO2)
2. Francisella tularensis
3. Burkholderia spp. (B. mallei/B. pseudomallei)
4. Yersinia pestis
5. Rickettsia prowazekii
The T2Biothreat Panel will not distinguish between detection of Burkholderia mallei and Burkholderia pseudomallei but will present valid detections as a positive detection of Burkholderia species.
The T2Biothreat Panel is intended to test individuals with signs and symptoms of infection from biothreat agents and/or individuals who are at risk for exposure or may have been exposed to these agents. The T2Biothreat Panel is indicated as an aid in the diagnosis of anthrax, tularemia, melioidosis, glanders, typhus fever and plague in response to suspected or confirmed bioterrorism events or outbreaks. Diagnosis of infection must be made in conjunction with clinical, epidemiologic and other laboratory data. Results are for the presumptive identification of Bacillus anthracis, Francisella tularensis, Burkholderia spp. (B. mallei/B. pseudomallei), Yersinia pestis and Rickettsia prowazekii. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. The definitive identification of Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis or Rickettsia prowazekii requires additional testing and confirmation procedures in consultation with the appropriate public health authorities for whom reports may be required. Positive results do not rule out co-infections with pathogens not included on the T2Biothreat Panel. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
The T2Biothreat Panel is indicated for use in laboratories that have the appropriate biosafety equipment, personal protective equipment (PPE), containment facilities, and personnel trained in the safe handling of clinical specimens potentially containing biothreat organisms.
The T2Biothreat Panel is indicated for use in laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.
This assay is not FDA-cleared or approved for testing blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231336: T2 Biothreat Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231336
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026