510(k) · Cleared
Recalled · Class II · 2024ADVIA Centaur Erythropoietin (EPO) assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics Limited · GGT Assay, Erythropoietin
Cleared on Aug 2, 2019 as substantially equivalent to K052223 (Beckman Coulter, Inc., 2006) after a 269-day review. Its family tree reaches back 3 generations to 1996. It has been recalled 2 times.
- Decided
- Aug 2, 2019
- Review
- 269 days
- Class
- Class II
- Product code
- GGT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952559 (1996). 7 ancestors in all, the oldest K902639 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK952559 Erythropoietin Immunoassay KitNichols Institute · 1996
- 2 generations backK980737 Advantage Chemiluminescence Erythropoietin ImmunoassayNichols Institute Diagnostics · 1999
- 1 generation backK052223 Access Epo AssayBeckman Coulter, Inc. · 2006 · Recalled
- This deviceK183088 ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952559 | Erythropoietin Immunoassay Kit | Nichols Institute | 1996 | — |
| −2 | K980737 | Advantage Chemiluminescence Erythropoietin Immunoassay | Nichols Institute Diagnostics | 1999 | — |
| −1 | K052223 | Access Epo Assay | Beckman Coulter, Inc. | 2006 | 1 |
| 0 (this device) | K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | 2019 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K052223 | Access Epo AssaySummary page 4…lassification: Class II Classification Panel: Hematology Product Code: GGT F. Legally marketed device to which equivalency is claimed: Beckman Coulter Access EPO Assay (K052223) Section_006 1 of 12 510(k) Summary v2 G. I… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2024 | Class II | Z-1280-2024 | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The… |
| Jan 24, 2024 | Class II | Z-1281-2024 | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K052223.
How does its category compare?
All GGT devicesGGT Assay, Erythropoietin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 ADVIA Centaur® Erythropoietin (EPO) assay is for in vitro diagnostic use in the quantitative measurement of erythropoietin in pediatric and adult human serum or plasma (K2-EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system.
Measurement of erythropoietin is used as an aid in the diagnosis of anemias and polycythemias..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183088: ADVIA Centaur Erythropoietin (EPO) assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183088
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