510(k) · Cleared

Cleared

Elecys Ige Assay

K984326510(k) TraditionalCleared Feb 8, 199967-day reviewClass II21 CFR 866.5510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boehringer Mannheim Corp. · JHR Radioimmunoassay, Immunoglobulins (D, E)

Cleared on Feb 8, 1999 after a 67-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Feb 8, 1999
Review: 67 days
Class: Class II
Product code: JHR
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK984326 Elecys Ige AssayBoehringer Mannheim Corp. · 1999
Descendant · cites it directly · 1 of its ownK061970 Elecsys Ige II ImmunoassayRoche Diagnostics · 2006
Descendant · 2 generations on · 0 of its ownK220178 Total Immunoglobulin E (IgE)Beckman Coulter, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all

K061970Elecsys Ige II ImmunoassayRoche Diagnostics · 2006 · cites it directly1descendant
K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc. · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K984326	Elecys Ige Assay	Boehringer Mannheim Corp.	1999	—
+1	K061970	Elecsys Ige II Immunoassay	Roche Diagnostics	2006	—
+2	K220178	Total Immunoglobulin E (IgE)	Beckman Coulter, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2022	1	0

FIG. 1 — Lineage of K984326, 1999–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	—	Boehringer Mannheim Enzymun-Test IgE Named without a submission number			—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061970	Elecsys Ige II Immunoassay	Roche Diagnostics	2006	1

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, K061970 (Roche Diagnostics, 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JHR devices

JHR 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

2007high 6 (2015) · low 0 (2007)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	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	6
2016	—	2
2017	—	1
2018	—	3
2019	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	4
2024	—	2
2025	—	3
2026	—	—

What is it indicated for?

For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Bocehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Determination of total serum IgE is useful as an aid in the disgnosis of allergic disease.

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/K984326 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984326: Elecys Ige Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984326

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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