(116 days)
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
Not Found
The provided text is a 510(k) clearance letter for the Endotoxin Activity Assay (EAA) device. It does not contain information about acceptance criteria, study details, or performance data of the device. The document primarily focuses on the regulatory clearance process, the device's intended use, and general FDA regulations.
Therefore, I cannot provide the requested information based on the given text. A typical 510(k) submission summary or a separate clinical study report would be required to answer these questions.
§ 866.3210 Endotoxin assay.
(a)
Identification. An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance entitled “Class II Special Controls Guidance Document: Endotoxin Assay.” See § 866.1(e) for the availability of this guidance document.