510(k) · Cleared
ClearedElecsys LH Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CEP Radioimmunoassay, Luteinizing Hormone
Cleared on Jan 24, 1997 as substantially equivalent to K900779 (Boehringer Mannheim Corp., 1990) after a 63-day review. Its family tree reaches back 1 generation to 1990. 14 later devices descend from it.
- Decided
- Jan 24, 1997
- Review
- 63 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900779 (1990). 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK900779 Enzymun Test (R) LHBoehringer Mannheim Corp. · 1990
- This deviceK964694 Elecsys LH AssayBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 13 of its ownK031299 Elecsys LH Calset IIRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 12 of its ownK033873 Elecsys C-Peptide CalsetRoche Diagnostics Corp. · 2004
- Descendant · 3 generations on · 10 of its ownK103221 Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics · 2010
- Descendant · 4 generations on · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- Descendant · 5 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K031299Elecsys LH Calset IIRoche Diagnostics Corp. · 2003 · cites it directly13descendants
- K033873Elecsys C-Peptide CalsetRoche Diagnostics Corp. · 2004 · 2 generations on12descendants
- K103221Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics · 2010 · 3 generations on10descendants
- K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · 4 generations on8descendants
- K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900779 | Enzymun Test (R) LH | Boehringer Mannheim Corp. | 1990 | — |
| 0 (this device) | K964694 | Elecsys LH Assay | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K031299 | Elecsys LH Calset II | Roche Diagnostics Corp. | 2003 | — |
| +2 | K033873 | Elecsys C-Peptide Calset | Roche Diagnostics Corp. | 2004 | — |
| +3 | K103221 | Elecys HGH Calset, Elecsys HGH Calcheck 5 | Roche Diagnostics | 2010 | — |
| +4 | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| +5 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 CEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K900779 | Enzymun Test (R) LHSummary page 2…quivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun® LH Assay (K900779). The following table compares the Elecsys® LH Assay with the predicate device, Enzymun® LH Assay. Specific data on the performa… | 1990 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031299 | Elecsys LH Calset II | 2003 | 13 |
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, K031299 (Roche Diagnostics Corp., 2003) has gone furthest, with 13 descendants of its own.
How does its category compare?
All CEP devicesCEP Radioimmunoassay, Luteinizing Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEP
FDA has decided no CEP device since 2007.
Median 510(k) review, days · CEP
Too few CEP 510(k)s in any year since 2007 to give a median.
Recalls per year · CEP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEP
1in 2023
MAUDE reports naming product code CEP, 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 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma.
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/K964694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964694: Elecsys LH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964694
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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