# K052223: Access Epo Assay

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 6, 2006 after 417 days
- Product code: GGT (Assay, Erythropoietin)
- Device class: 2
- Regulation: 21 CFR 864.7250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952559 (1996). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936016: Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa), R&D Systems, Inc. (1994) Summary page 1.
- K983203: Immulite Epo, Model #'S Lkepz & LKEP1, Diagnostic Products Corp. (1999) Summary page 1.
- K980737: Advantage Chemiluminescence Erythropoietin Immunoassay, Nichols Institute Diagnostics (1999) Summary page 1.
- K992799: Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit, Sangui Biotech, Inc. (2000) Summary page 1.

## Most influential descendants
- K240182: Access EPO (2024), 0 descendants of its own
- K183088: ADVIA Centaur Erythropoietin (EPO) assay (2019), 0 descendants of its own

## Recalls of this device
- Feb 3, 2025 · Class II · Z-1249-2025: Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable fal

## Indications for use
The Access® EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias. The Access EPO calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K052223
Methodology: https://510kreport.com/methodology