K172713 is an FDA 510(k) clearance for the Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set. This device is classified as a Procalcitonin Assay (Class II - Special Controls, product code PRI).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on December 10, 2017, 93 days after receiving the submission on September 8, 2017.
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 | K172713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2017 |
| Decision Date | December 10, 2017 |
| Days to Decision | 93 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). |