510(k) · Cleared
Recalled · Class II · 2025Access Epo Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · GGT Assay, Erythropoietin
Cleared on Oct 6, 2006 as substantially equivalent to K936016 (R&D Systems, Inc., 1994) and 3 other predicates after a 417-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2006
- Review
- 417 days
- Class
- Class II
- Product code
- GGT
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K952559 (1996). 6 ancestors in all, the oldest K902639 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952559 Erythropoietin Immunoassay KitNichols Institute · 1996
- 1 generation backK980737 Advantage Chemiluminescence Erythropoietin ImmunoassayNichols Institute Diagnostics · 1999
- This deviceK052223 Access Epo AssayBeckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK240182 Access EPOBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK183088 ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 2019 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952559 | Erythropoietin Immunoassay Kit | Nichols Institute | 1996 | — |
| −1 | K980737 | Advantage Chemiluminescence Erythropoietin Immunoassay | Nichols Institute Diagnostics | 1999 | — |
| 0 (this device) | K052223 | Access Epo Assay | Beckman Coulter, Inc. | 2006 | — |
| +1 | K240182 | Access EPO | Beckman Coulter, Inc. | 2024 | — |
| +1 | K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | 2019 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GGT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GGT device
- #1 K240182 Access EPOscore 7.8 · 3 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K936016 | Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)Summary page 1…y Product Classification Device Class - II and Code: Classification Code - GGT (EPO Assay) and JIT (Calibrators) Predicate Devices: K936016 - Quantikine IVD Erythropoietin ELISA Kit - R &DSystems, Inc. K983203- IMMULITE EPO - Diagnostic Pr… | 1994 |
| * | K983203 | Immulite Epo, Model #'S Lkepz & LKEP1Summary page 1…- GGT (EPO Assay) and JIT (Calibrators) Predicate Devices: K936016 - Quantikine IVD Erythropoietin ELISA Kit - R &DSystems, Inc. K983203- IMMULITE EPO - Diagnostic Products Corp. K980737 - Nichols Advantage Chemiluminescent Erythropoiet… | 1999 |
| * | K980737 | Advantage Chemiluminescence Erythropoietin ImmunoassaySummary page 1…Quantikine IVD Erythropoietin ELISA Kit - R &DSystems, Inc. K983203- IMMULITE EPO - Diagnostic Products Corp. K980737 - Nichols Advantage Chemiluminescent Erythropoietin Immunoassay - Nichols Institute Diagnostics… | 1999 |
| * | K992799 | Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitSummary page 1…K980737 - Nichols Advantage Chemiluminescent Erythropoietin Immunoassay - Nichols Institute Diagnostics K992799 - Sangui Bio Tech, Inc. EPO [Erythropoietin] ELISA Kit Device Description: The Access® EPO assay consists of the reagen… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2025 | Class II | Z-1249-2025 | Unknown/Undetermined by firm | 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 falsely decreased results, which may lead… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K240182 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGT devicesGGT Assay, Erythropoietin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GGT
Too few GGT 510(k)s in any year since 2007 to give a median.
Recalls per year · GGT
No recall names GGT since 2007.
Adverse event reports per year · GGT
3in 2012
MAUDE reports naming product code GGT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (115 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052223: Access Epo Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052223
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026