# K183176: Endotoxin Activity Assay (EAA)

- Pathway: 510(k) (Special)
- Applicant: Spectral Medical, Inc.
- Decided: Mar 12, 2019 after 116 days
- Product code: NGS (Assay, Endotoxin Activity, Chemiluminescent)
- Device class: 2
- Regulation: 21 CFR 866.3210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens. The information, when used in conjunction with other clinical information and other relevant diagnostic tests aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.

Source page: https://510kreport.com/device/K183176
Methodology: https://510kreport.com/methodology