# K983203: Immulite Epo, Model #'S Lkepz & LKEP1

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jul 12, 1999 after 301 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
Longest line of descent: 1 generation back to K902639 (1990). 1 ancestor in all.
3 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)
- K902639: Epo-Trac (TM) 125I Radioimmunoassay (Ria), Incstar Corp. (1990) Summary page 1.

## Most influential descendants
- 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

## Indications for use
IMMULITE EPO is a solid-phase, two-site sequential chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of erythropoietin (EPO) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis of anemias and polycythemias.

Source page: https://510kreport.com/device/K983203
Methodology: https://510kreport.com/methodology