# DEN220044: Active Anthrax DetectTM Plus Rapid Test

- Pathway: De Novo (Direct)
- Applicant: InBios International, Inc.
- Decided: Feb 3, 2023 after 210 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K232545: The SensiTox B. anthracis Toxin Test (2023), 0 descendants of its own

## Indications for use
The Active Anthrax Detect Plus Rapid Test point-of-care diagnostic test for pulmonary anthrax is an in vitro immunochromatographic device for use as an aid in the diagnosis of inhalation anthrax. It provides visual and rapid qualitative detection of lethal factor of Bacillus anthracis (B. anthracis). The test can be used to test serum and venous whole blood (dipotassium EDTA, sodium citrate, and sodium heparin). The assay is indicated for testing samples from individuals who have signs and symptoms consistent with inhalation anthrax and a likelihood of exposure. This test is intended for use by military personnel, medical, and/or healthcare professionals only. The diagnosis of B. anthracis infection must be based on history, signs, symptoms, exposure likelihood, and additional laboratory evidence. A positive Active Anthrax Detect Plus Rapid Test result is presumptively diagnostic for B. anthracis infection. 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. This assay is for Rx use.

Source page: https://510kreport.com/device/DEN220044
Methodology: https://510kreport.com/methodology