21 CFR 866.3210 — Assay, Endotoxin Activity, Chemiluminescent
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3210
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NGS | Assay, Endotoxin Activity, Chemiluminescent | 2 | 2 | |
| NTM | Antigen, Inflammatory Response Marker, Sepsis | 2 | 3 |
Special Controls
NGS — Assay, Endotoxin Activity, Chemiluminescent
*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.
eCFR
NGS — Assay, Endotoxin Activity, Chemiluminescent
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.
Ecfr Llm
NTM — Antigen, Inflammatory Response Marker, Sepsis
*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.
eCFR
