NGS · Assay, Endotoxin Activity, Chemiluminescent
Microbiology · 21 CFR 866.3210 · Class 2
Overview
| Product Code | NGS |
|---|---|
| Device Name | Assay, Endotoxin Activity, Chemiluminescent |
| Regulation | 21 CFR 866.3210 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183176 | Endotoxin Activity Assay (EAA) | Spectral Medical, Inc. | Mar 12, 2019 | SESE |
| DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | Spectral Diagnostics, Inc. | Jun 16, 2003 | DENG |
Top Applicants
- Spectral Diagnostics, Inc. — 1 clearance
- Spectral Medical, Inc. — 1 clearance
