510(k) · Cleared
ClearedElecsys Afp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics GmbH · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on May 1, 1998 as substantially equivalent to K973351 (Boehringer Mannheim Corp., 1997) after a 23-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- May 1, 1998
- Review
- 23 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973351 (1997). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973351 Elecsys AfpBoehringer Mannheim Corp. · 1997
- This deviceK981282 Elecsys AfpRoche Diagnostics GmbH · 1998
- Descendant · cites it directly · 0 of its ownK220176 Elecsys AFPRoche Diagnostics · 2022
- Descendant · cites it directly · 0 of its ownK043095 Roche Diagnostics Elecsys Afp Calset IIRoche Diagnostics Corp. · 2004
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 |
|---|---|---|---|---|---|
| −1 | K973351 | Elecsys Afp | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K981282 | Elecsys Afp | Roche Diagnostics GmbH | 1998 | — |
| +1 | K220176 | Elecsys AFP | Roche Diagnostics | 2022 | — |
| +1 | K043095 | Roche Diagnostics Elecsys Afp Calset II | Roche Diagnostics Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2022 | 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 LOJ? 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 LOJ device
- #1 K220176 Elecsys AFPscore 4.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K973351 | Elecsys AfpSummary page 2…ys 1010 and 2010 immunoassay analyzers. The Roche Diagnostics/Boehringer Mannheim Elecsys® AFP Assay has been approved for use on the Elecsys 2010 immunoassay analyzer (K973351). The application of the Elecsys® AFP Assay on the Elecsys 1010 immunoassay analyzer is substantially equivalent to the same assa… | 1997 |
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)
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, K220176 (Roche Diagnostics, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LOJ devicesLOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOJ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LOJ
Too few LOJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LOJ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOJ
5in 2025
MAUDE reports naming product code LOJ, 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 | — | 1 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 1 | 7 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
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/K981282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981282: Elecsys Afp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981282
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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