# DEN030002: Endotoxin Activity Assay (Eaa) Device

- Pathway: De Novo (Post-NSE)
- Applicant: Spectral Diagnostics, Inc.
- Decided: Jun 16, 2003 after 63 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K040887: B-R-a-H-M-S PCT Lia (2005), 2 descendants of its own
- K070310: B R a H M S PCT Sensitive Kryptor Test System (2008), 1 descendant of its own
- K240041: IVD CAPSULE PSP; abioSCOPE (2024), 0 descendants of its own

Source page: https://510kreport.com/device/DEN030002
Methodology: https://510kreport.com/methodology