510(k) · Cleared
ClearedAdvantage Chemiluminescence Erythropoietin Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · GGT Assay, Erythropoietin
Cleared on Mar 23, 1999 as substantially equivalent to K952559 (Nichols Institute, 1996) after a 391-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Mar 23, 1999
- Review
- 391 days
- Class
- Class II
- Product code
- GGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952559 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952559 Erythropoietin Immunoassay KitNichols Institute · 1996
- This deviceK980737 Advantage Chemiluminescence Erythropoietin ImmunoassayNichols Institute Diagnostics · 1999
- Descendant · cites it directly · 2 of its ownK052223 Access Epo AssayBeckman Coulter, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK240182 Access EPOBeckman Coulter, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK183088 ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952559 | Erythropoietin Immunoassay Kit | Nichols Institute | 1996 | — |
| 0 (this device) | K980737 | Advantage Chemiluminescence Erythropoietin Immunoassay | Nichols Institute Diagnostics | 1999 | — |
| +1 | K052223 | Access Epo Assay | Beckman Coulter, Inc. | 2006 | 1 |
| +2 | K240182 | Access EPO | Beckman Coulter, Inc. | 2024 | — |
| +2 | K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | 2019 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K952559 | Erythropoietin Immunoassay KitSummary page 1…me: Erythropoletin Assay Legally Marketed Equivalent Device Name: We are claiming substantial equivalence to the assay cleared in Nichols Institute Diagnostics’ 510(k) K952559 for the Chemiluminescence Erythropoletin Immunoassay Kit. Description of the Device: The Nichols Advanlagem EPO assay is a two-… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052223 | Access Epo Assay | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K052223 (Beckman Coulter, Inc., 2006) has gone furthest, with 2 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 Nichols Advantage™ Chemiluminescence Erythropoietin Immunoassay is intended for use with the Nichols Advantage™ Specialty System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980737: Advantage Chemiluminescence Erythropoietin Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980737
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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