Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Device Code: 3580

Product Code(s): PTF

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 Classification Information

Device Type ID3580
Device NameAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Physical StateIn Vitro Diagnostic Device
Technical MethodLatex Particle Enhanced Immunoturbidimetric Method Intended For The Quantitative Determination Of PCT In Serum, EDTA Or Lithium Heparin Plasma.
Target AreaDetection And Determination Of Procalcitonin (PCT) Concentration In Serum Or Plasma
Regulation DescriptionDevice To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3215 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePTF
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3580
DeviceAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Product CodePTF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDevice To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis.
CFR Regulation Number866.3215 [🔎]
Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:32:44

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