| Device |
assay to measure pct to aid in the risk assessment of critically ill patients on their first day of icu admission |
| Regulation Description |
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis. |
| Definition |
Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock |
| Physical State |
In vitro diagnostic device |
| Technical Method |
Latex particle enhanced immunoturbidimetric method intended for the quantitative determination of PCT in serum, EDTA or lithium heparin plasma. |
| Target Area |
Detection and determination of procalcitonin (PCT) concentration in serum or plasma |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | PTF |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3215
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
