510(k) · Cleared
ClearedElecsys Afp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Nov 21, 1997 after a 77-day review; its predicate, P860044, is listed below. 3 later devices descend from it.
- Decided
- Nov 21, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 1
1 ancestor in all. 3 later devices descend from it, 1 citing it directly.
- This deviceK973351 Elecsys AfpBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 2 of its ownK981282 Elecsys AfpRoche Diagnostics GmbH · 1998
- Descendant · 2 generations on · 0 of its ownK220176 Elecsys AFPRoche Diagnostics · 2022
- Descendant · 2 generations on · 0 of its ownK043095 Roche Diagnostics Elecsys Afp Calset IIRoche Diagnostics Corp. · 2004
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 |
|---|---|---|---|---|---|
| 0 (this device) | K973351 | Elecsys Afp | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K981282 | Elecsys Afp | Roche Diagnostics GmbH | 1998 | — |
| +2 | K220176 | Elecsys AFP | Roche Diagnostics | 2022 | — |
| +2 | K043095 | Roche Diagnostics Elecsys Afp Calset II | Roche Diagnostics Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | P860044 | Enzymun-Test{R} Afp FDA lists this PMA only through its supplements; the earliest we hold is P860044/S001 (Aug 3, 1990). Summary page 1…P Common name: Alpha-Fetoprotein assay Classification name: Alpha-Fetoprotein test kit for testicular cancer We claim substantial equivalence to the Enzymun-Test® AFP (P860044). The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes. o Istincubation: 15 ul… |
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 |
|---|---|---|---|
| K981282 | Elecsys Afp | 1998 | 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?
- Of its descendants, K981282 (Roche Diagnostics GmbH, 1998) has gone furthest, with 2 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 α-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 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/K973351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973351: 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/K973351
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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