K192871 is an FDA 510(k) clearance for the B. anthracis Real-time PCR Assay. This device is classified as a Assay, Nucleic Acid Amplification, Bacillus Anthracis (Class II - Special Controls, product code NHT).
Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on November 7, 2019, 30 days after receiving the submission on October 8, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3045. 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) Number | K192871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2019 |
| Decision Date | November 07, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NHT — Assay, Nucleic Acid Amplification, Bacillus Anthracis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3045 |
| Definition | An Invitro Diagnostic Device Used To Presumptively Detect The Presence Or Absence Of B. Anthracis Directly In Blood Specimens Or Suspicious Culture Growth. |