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-a
| Device Type ID | 3578 |
| Device Name | Procalcitonin Assay |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Immunoassay, ELISA |
| Target Area | Human Serum And EDTA Or Heparin Plasma Specimens. |
| Regulation Description | Device To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3215 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PRI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3578 |
| Device | Procalcitonin Assay |
| Product Code | PRI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Device To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis. |
| CFR Regulation Number | 866.3215 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRAHMS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FISHER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FISHER DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 3 |