Cleared Traditional

The SensiTox B. anthracis Toxin Test

K232545 · First Light Diagnostics, Inc. · Microbiology
Nov 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K232545 is an FDA 510(k) clearance for the The SensiTox B. anthracis Toxin Test, a Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples (Class II — Special Controls, product code QUU), submitted by First Light Diagnostics, Inc. (Chelmsford, US). The FDA issued a Cleared decision on November 20, 2023, 90 days after receiving the submission on August 22, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3046.

Submission Details

510(k) Number K232545 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2023
Decision Date November 20, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QUU — Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3046
Definition A Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Species (spp.) Is A Prescription In Vitro Diagnostic Device Used To Detect And Presumptively Identify B. Anthracis And Other Bacillus Spp. In Human Clinical Samples As An Aid In The Diagnosis Of Anthrax And Other Diseases Caused By Bacillus Spp. This Device Is Simple To Use And Does Not Involve Sample Manipulation Or Measurement Of An Analyte That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. This Device May Be Used To Aid In The Presumptive Diagnosis Of Anthrax In Individuals Who Have Signs And Symptoms Consistent With Anthrax And A Likelihood Of Exposure. Bacillus Infections Include Anthrax (cutaneous, Inhalational, Or Gastrointestinal) Caused By B. Anthracis, Gastrointestinal Disease, Non-gastrointestinal Infections, And An Anthrax-like Illness Caused By B. Cereus.