510(k) · Cleared
ClearedImmulite Epo, Model #'S Lkepz & LKEP1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · GGT Assay, Erythropoietin
Cleared on Jul 12, 1999 as substantially equivalent to K902639 (Incstar Corp., 1990) after a 301-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 301 days
- Class
- Class II
- Product code
- GGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902639 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK902639 Epo-Trac (TM) 125I Radioimmunoassay (Ria)Incstar Corp. · 1990
- This deviceK983203 Immulite Epo, Model #'S Lkepz & LKEP1Diagnostic Products Corp. · 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 | K902639 | Epo-Trac (TM) 125I Radioimmunoassay (Ria) | Incstar Corp. | 1990 | — |
| 0 (this device) | K983203 | Immulite Epo, Model #'S Lkepz & LKEP1 | Diagnostic Products Corp. | 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 |
|---|---|---|---|
| * | K902639 | Epo-Trac (TM) 125I Radioimmunoassay (Ria)Summary page 1…eles, CA 90045-5597 Establishment Registration ‘ Number: DPC'’s Registration Number 1s 2017183 Substantially Equivalent Predicate Device: Incstar’s EPO-Trac '#’I RIA (K902639) Description of the Device: IMMULITE® EPO is a solid-phase, two-site sequential chemiluminescent enzyme immunometric assay for… | 1990 |
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?
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.
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/K983203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983203: Immulite Epo, Model #'S Lkepz & LKEP1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983203
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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