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.
| Device Type ID | 3570 |
| Device Name | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Immunoassay, ELISA |
| Target Area | Detection And Determination The Concentration Of PCT (procalcitonin) In 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 | PMT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3570 |
| Device | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Product Code | PMT |
| 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 | ||
GRANTED | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 4 |
Incorrect Or Inadequate Test Results | 4 |
High Test Results | 4 |
Tip | 1 |
Device Subassembly | 1 |
Cell | 1 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roche Diagnostics Corporation | II | Apr-04-2018 |