← Product Code [NGS](/submissions/MI/subpart-d%E2%80%94serological-reagents/NGS) · DEN030002

# ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (DEN030002)

_Spectral Diagnostics, Inc. · NGS · Jun 16, 2003 · Microbiology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NGS/DEN030002

## Device Facts

- **Applicant:** Spectral Diagnostics, Inc.
- **Product Code:** [NGS](/submissions/MI/subpart-d%E2%80%94serological-reagents/NGS.md)
- **Decision Date:** Jun 16, 2003
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 866.3210
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NGS/DEN030002](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NGS/DEN030002)

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