K200236 is an FDA 510(k) clearance for the VITROS BRAHMS PCT Reagent Pack and Calibrators. This device is classified as a Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (Class II - Special Controls, product code PMT).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on February 25, 2020, 26 days after receiving the submission on January 30, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. An Assay Used To Determine The Level Of Procalcitonin (pct) In Human Serum And Plasma As An Aid In Assessing The Mortality For Patients Diagnosed With Severe Sepsis Or Septic Shock..
| 510(k) Number | K200236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2020 |
| Decision Date | February 25, 2020 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PMT — Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| Definition | An Assay Used To Determine The Level Of Procalcitonin (pct) In Human Serum And Plasma As An Aid In Assessing The Mortality For Patients Diagnosed With Severe Sepsis Or Septic Shock. |