Cleared Traditional

K232545 - The SensiTox B. anthracis Toxin Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K232545 is an FDA 510(k) clearance for the The SensiTox B. anthracis Toxin Test. Classified as Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples (product code QUU), Class II - Special Controls.

Submitted by First Light Diagnostics, Inc. (Chelmsford, US). The FDA issued a Cleared decision on November 20, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3046 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all First Light Diagnostics, Inc. devices

Submission Details

510(k) Number K232545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.