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510(k) Data Aggregation
K Number
K183176Device Name
Endotoxin Activity Assay (EAA)
Manufacturer
Spectral Medical Inc.
Date Cleared
2019-03-12
(116 days)
Product Code
NGS
Regulation Number
866.3210Why did this record match?
Product Code :
NGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens. The information, when used in conjunction with other clinical information and other relevant diagnostic tests aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.
Device Description
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K Number
DEN030002Device Name
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
Manufacturer
SPECTRAL DIAGNOSTICS, INC.
Date Cleared
2003-06-16
(63 days)
Product Code
NGS
Regulation Number
866.3210Why did this record match?
Product Code :
NGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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