Not Cleared Direct

DEN220044 - Active Anthrax DetectTM Plus Rapid Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220044 · InBios International, Inc. · Microbiology device
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Feb 2023
Decision
210d
Days
Class 2
Risk

DEN220044 is an FDA 510(k) submission (not cleared) for the Active Anthrax DetectTM Plus Rapid 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 InBios International, Inc. (Seattle, US). The FDA issued a Not Cleared (DENG) decision on February 3, 2023 after a review of 210 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all InBios International, Inc. devices

Submission Details

510(k) Number DEN220044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 08, 2022
Decision Date February 03, 2023
Days to Decision 210 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 102d · This submission: 210d
Pathway characteristics

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.