# K902639: Epo-Trac (TM) 125I Radioimmunoassay (Ria)

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Aug 22, 1990 after 69 days
- Product code: GGT (Assay, Erythropoietin)
- Device class: 2
- Regulation: 21 CFR 864.7250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983203: Immulite Epo, Model #'S Lkepz & LKEP1 (1999), 3 descendants of its own
- K052223: Access Epo Assay (2006), 2 descendants of its own
- K240182: Access EPO (2024), 0 descendants of its own
- K183088: ADVIA Centaur Erythropoietin (EPO) assay (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K902639
Methodology: https://510kreport.com/methodology