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 | ||
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Manufacturer | Decision | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 |