# K232545: The SensiTox B. anthracis Toxin Test

- Pathway: 510(k) (Traditional)
- Applicant: First Light Diagnostics, Inc.
- Decided: Nov 20, 2023 after 90 days
- Product code: QUU (Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples)
- Device class: 2
- Regulation: 21 CFR 866.3046
- 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 DEN220044 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220044: Active Anthrax DetectTM Plus Rapid Test, InBios International, Inc. (2023) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K232545
Methodology: https://510kreport.com/methodology