K160729 is an FDA 510(k) clearance for the Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5. 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 Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 13, 2016, 89 days after receiving the submission on March 16, 2016.
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 | K160729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2016 |
| Decision Date | June 13, 2016 |
| Days to Decision | 89 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. |