Endotoxin Activity Assay (EAA)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183176 FDA 510(k)
- FDA Product Code
- NGS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3210 FDA 510(k)
- Regulation Number
- 866.3210 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endotoxin Activity Assay (EAA) is a chemiluminescent bioassay designed to measure endotoxin activity in human whole blood. Classified as an assay under product code NGS and regulation number 866.3210, it detects endotoxin-induced immune responses via the oxidative burst reaction of activated neutrophils. This method relies on complement-coated lipopolysaccharide (LPS)-IgM immune complexes to quantify endotoxin activity, serving as a diagnostic tool in microbiology. The device is intended for research and clinical applications where endotoxin monitoring is critical.
The EAA is supplied as a single-use assay kit and is regulated under FDA 510(k) clearance (K183176) with a special review designation in the Microbiology advisory committee. It is intended for use in laboratory settings, requiring sterile handling and proper storage as per manufacturer instructions. The assay is classified as a Class II medical device, with no specific MRI safety considerations noted. No information on reusable components or additional sterility requirements beyond standard assay protocols is provided.
Frequently asked questions
What is the Endotoxin Activity Assay (EAA) used for?
The EAA is a chemiluminescent bioassay designed to measure endotoxin activity in human whole blood. It quantifies endotoxin-induced immune responses by detecting the oxidative burst reaction of activated neutrophils, triggered by complement-coated lipopolysaccharide (LPS)-IgM immune complexes. This makes it useful for research and clinical applications where precise endotoxin monitoring is critical, such as in microbiology diagnostics.
How is the EAA supplied, and is it single-use?
The EAA is supplied as a single-use assay kit, meaning each kit is intended for one-time use only. This design ensures consistency and reliability in results while minimizing the risk of cross-contamination or carryover between tests. Proper sterile handling and adherence to manufacturer instructions are essential for accurate performance.
What are the key storage and handling requirements for the EAA?
The EAA requires sterile handling and storage as per the manufacturer’s guidelines to maintain its integrity and accuracy. Since it is a single-use kit, it should be stored in a clean, dry environment away from direct light and extreme temperatures until use. Avoid exposure to contaminants or moisture, as these could compromise the assay’s sensitivity or reliability.
Is the EAA intended for reuse, or does it have reusable components?
The EAA is explicitly designed as a single-use assay kit, with no reusable components specified. This ensures each test is performed under controlled conditions, reducing variability and maintaining the assay’s precision. Reuse is not recommended or supported by the manufacturer, as it could introduce errors or contamination.
What regulatory pathway does the EAA follow, and where is it cleared?
The EAA is cleared under the FDA’s 510(k) pathway with the clearance number K183176, granted through a special review designation in the Microbiology Advisory Committee (MI). It falls under product code NGS and regulation number 866.3210, classifying it as a Class II medical device. The clearance confirms its substantial equivalence to a predicate device, ensuring it meets regulatory standards for safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EAA™ for Clinicians and Researchers - Spectral Medical Inc, Spectral's EAA™, PMX and Reagents Product Line - Spectral Medical Inc, Spectral Medical: Endotoxic Septic Shock | EAA™ & PMX
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183176 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectral Medical Inc.
- FDA Applicant
- Spectral Medical, Inc.
Sources (1)
- FDA 510(k) K183176 24 fields · synced Oct 1, 2026