510(k) · Cleared
ClearedThe SensiTox B. anthracis Toxin Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Light Diagnostics, Inc. · QUU Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
Cleared on Nov 20, 2023 as substantially equivalent to DEN220044 (InBios International, Inc., 2023) after a 90-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Nov 20, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- QUU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220044 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220044 Active Anthrax DetectTM Plus Rapid TestInBios International, Inc. · 2023
- This deviceK232545 The SensiTox B. anthracis Toxin TestFirst Light Diagnostics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220044 | Active Anthrax DetectTM Plus Rapid Test | InBios International, Inc. | 2023 | — |
| 0 (this device) | K232545 | The SensiTox B. anthracis Toxin Test | First Light Diagnostics, 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 QUU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN220044 | Active Anthrax DetectTM Plus Rapid TestSummary page 4…Code: QUU Predicate Device: InBios International, Inc. Active Anthrax Detect Plus Rapid Test (DEN220044) Section 5 - Page 1 of 15 === Page… | 2023 |
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 no recall.
How does its category compare?
All QUU devicesQUU Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QUU
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QUU
Too few QUU 510(k)s in any year since 2007 to give a median.
Recalls per year · QUU
No recall names QUU since 2007.
Adverse event reports per year · QUU
No MAUDE report names QUU 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 | 0 | — | 0 | — |
What is it indicated for?
The SensiTox B. anthracis Toxin Test for use with the MultiPath Analyzer, is a qualitative immunofluorescence assay to aid in the diagnosis of inhalation anthrax. The test is intended for the rapid, qualitative detection of lethal factor, a biomarker associated with Bacillus anthracis (B. anthracis). The test can be used with whole blood collected with dipotassium EDTA anticoagulant by venipuncture. This test is indicated for testing samples from…
Read the full statement (280 words)
The SensiTox B. anthracis Toxin Test for use with the MultiPath Analyzer, is a qualitative immunofluorescence assay to
aid in the diagnosis of inhalation anthrax. The test is intended for the rapid, qualitative detection of lethal factor, a
biomarker associated with Bacillus anthracis (B. anthracis). The test can be used with whole blood collected with
dipotassium EDTA anticoagulant by venipuncture. This test is indicated for testing samples from individuals who have
signs and symptoms consistent with inhalation anthrax and a likelihood of exposure to B. anthracis. A positive SensiTox
B. anthracis Toxin Test result is presumptively diagnostic for B. anthracis infection. Diagnosis of B. anthracis infection
must be made in conjunction with medical history, likelihood of exposure, signs, and symptoms of disease, as well as
other laboratory evidence. The definitive identification of B. anthracis from blood samples requires additional testing and
confirmation procedures in consultation with public health or other authorities for whom reports are required. Testing
should be performed and reported in accordance with current guidelines provided by the appropriate public health
authorities. The level of lethal factor present in blood from individuals with early systemic infection is unknown.
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.
Laboratories performing the SensiTox B. anthracis Toxin Test must have the appropriate biosafety equipment, personal
protective equipment (PPE), containment facilities, and personnel trained in the safe handling of clinical specimens
potentially containing B. anthracis.
The SensiTox B. anthracis Toxin Test is for prescription use only.
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/K232545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232545: The SensiTox B. anthracis Toxin Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232545
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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