Assay, Nucleic Acid Amplification, Bacillus Anthracis
The Nucleic Acid Amplification Assay for Bacillus Anthracis (anthrax) is an in vitro diagnostic device used to presumptively detect the presence or absence of B. anthracis directly in blood specimens or suspicious culture growth. It falls under FDA Class 2 (Special Controls), meaning it requires a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is NHT, regulated under 21 CFR 866.3045, and it belongs to the Microbiology specialty. It is not an implant, not life-sustaining, and not GMP exempt.
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Basic Information
- Product Code
- NHT
- Device Class
- FDA class 2
- Regulation Number
- 866.3045
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192871 | B. anthracis Real-time PCR Assay | Nov 07, 2019 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | May 22, 2014 | Substantially Equivalent | Centers For Disease Control and Prevention (CDC) |
| K131930 | JBAIDS ANTHRAX DETECTION KIT | Aug 05, 2013 | Substantially Equivalent | Biofire Diagnostics, Inc. |
| K072631 | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | Dec 20, 2007 | Substantially Equivalent | Idaho Technology, Inc. |
| K071188 | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | May 21, 2007 | Substantially Equivalent | Idaho Technology, Inc. |
| K051713 | JBAIDS ANTHRAC DETECTION SYSTEM | Nov 18, 2005 | Substantially Equivalent | Idaho Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.