DEN220044 is an FDA 510(k) submission for the Active Anthrax DetectTM Plus Rapid Test. This device is classified as 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 InBios International, Inc. (Seattle, US). The FDA issued a Not Cleared (DENG) decision on February 3, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3046. 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..
| 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 | - |
| 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. |