510(k) · Cleared
ClearedElecsys Ige II Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JHR Radioimmunoassay, Immunoglobulins (D, E)
Cleared on Aug 31, 2006 as substantially equivalent to K984326 (Boehringer Mannheim Corp., 1999) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Aug 31, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- JHR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961481 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961481 | Elecsys 2010 Analyzer | Boehringer Mannheim Corp. | 1996 | 6 |
| 0 (this device) | K061970 | Elecsys Ige II Immunoassay | Roche Diagnostics | 2006 | — |
| +1 | K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JHR? 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? (2)
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 |
|---|---|---|---|
| * | K984326 | Elecys Ige AssaySummary page 1…o another device equivalence legally marketed in the United States. Elecsys IgE II (modified) assay is equivalent to the Elecsys IgE immunoassay (K984326, K961481/A003). Both products are intended for use in the quantitative determination of IgE in… | 1999 |
| * | K961481 | Elecsys 2010 AnalyzerSummary page 1…device equivalence legally marketed in the United States. Elecsys IgE II (modified) assay is equivalent to the Elecsys IgE immunoassay (K984326, K961481/A003). Both products are intended for use in the quantitative determination of IgE in serum a… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220178 | Total Immunoglobulin E (IgE) | 2022 | 0 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K220178 (Beckman Coulter, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JHR devicesJHR Radioimmunoassay, Immunoglobulins (D, E): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHR
FDA has decided no JHR device since 2007.
Median 510(k) review, days · JHR
Too few JHR 510(k)s in any year since 2007 to give a median.
Recalls per year · JHR
No recall names JHR since 2007.
Adverse event reports per year · JHR
3in 2025
MAUDE reports naming product code JHR, 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 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma.
Determination of total IgE is useful as an aid in the diagnosis of allergic diseases.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170
(Elecsys module) 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/K061970 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061970: Elecsys Ige II Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061970
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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