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
| Device Type ID | 3580 |
| Device Name | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission |
| 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 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 | PTF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3580 |
| Device | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission |
| Product Code | PTF |
| 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 | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |