K181002 is an FDA 510(k) clearance for the Atellica IM BRAHMS Procalcitonin (PCT). 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 Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 16, 2018, 91 days after receiving the submission on April 16, 2018.
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 | K181002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2018 |
| Decision Date | July 16, 2018 |
| Days to Decision | 91 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. |