ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
Device Facts
| Record ID | DEN030002 |
|---|---|
| Device Name | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
| Applicant | Spectral Diagnostics, Inc. |
| Product Code | NGS · Microbiology |
| Decision Date | Jun 16, 2003 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 866.3210 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
