K192815 is an FDA 510(k) clearance for the Elecsys BRAHMS PCT. This device is classified as a Procalcitonin Assay (Class II - Special Controls, product code PRI).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 9, 2020, 160 days after receiving the submission on October 1, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. To Aid In Decision Making On Antibiotic Therapy, Including Antibiotic Initiation And Discontinuation, For Inpatients Or Patients In The Emergency Department, With Suspected Or Confirmed Lower Respiratory Tract Infections (lrti) Defined As Community-acquired Pneumonia (cap), Acute Bronchitis, And Acute Exacerbation Of Chronic Obstructive Pulmonary Disease (aecopd)..
| 510(k) Number | K192815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2019 |
| Decision Date | March 09, 2020 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PRI — Procalcitonin Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| Definition | To Aid In Decision Making On Antibiotic Therapy, Including Antibiotic Initiation And Discontinuation, For Inpatients Or Patients In The Emergency Department, With Suspected Or Confirmed Lower Respiratory Tract Infections (lrti) Defined As Community-acquired Pneumonia (cap), Acute Bronchitis, And Acute Exacerbation Of Chronic Obstructive Pulmonary Disease (aecopd). |