K220262 is an FDA 510(k) clearance for the Dimension EXL LOCI BRAHMS Procalcitonin (PCT). This device is classified as a Procalcitonin Assay (Class II - Special Controls, product code PRI).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 26, 2022, 207 days after receiving the submission on January 31, 2022.
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 | K220262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2022 |
| Decision Date | August 26, 2022 |
| Days to Decision | 207 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). |