Device |
device to detect and measure procalcitonin (pct) in human clinical 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. |
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. |
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 Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PMT |
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 |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |