510(k) · Cleared
ClearedImmulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Diagnostics · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on May 11, 2011 as substantially equivalent to K021206 (Diagnostic Products Corp., 2002) and 1 other predicate after a 405-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- May 11, 2011
- Review
- 405 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K021206 (2002). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK021206 Immulite 2000 Specific AllergensDiagnostic Products Corp. · 2002 · Recalled
- This deviceK100910 Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2011
- Descendant · cites it directly · 1 of its ownK112523 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK132801 Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc. · 2014
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 | K021206 | Immulite 2000 Specific Allergens | Diagnostic Products Corp. | 2002 | 1 |
| 0 (this device) | K100910 | Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 | Siemens Medical Solutions Diagnostics | 2011 | — |
| +1 | K112523 | Immulite 2000 3GALLERGY Specific Ige Assay Kit | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +2 | K132801 | Immulite 2000 Systems 3GALLERGY Specific Ige Assay | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 DHB? 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 DHB device
- #1 K260331 IMMULITE 2000 3gAllergy Specific IgE Vantage…score 12.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0013134 | Unnamed device Number could not be read | |
| * | K021206 | Immulite 2000 Specific AllergensSummary page 2…5 F279L_2 - Chili Pepper ,10 F2361_2- Whey FDA clearance was previously obtained for the assay kit and 196 specific allergens and allergen panels (KO013134, K021206, KO013135 and K021208). Please note that the FDA clearances indicated above were in the name of Diagnostic Products Corporation w… | 2002 |
| Kept off the family tree | K0013135 | Unnamed device Number could not be read | |
| * | K021208 | Immulite 2000 Mixed Allergen PanelsSummary page 2…li Pepper ,10 F2361_2- Whey FDA clearance was previously obtained for the assay kit and 196 specific allergens and allergen panels (KO013134, K021206, KO013135 and K021208). Please note that the FDA clearances indicated above were in the name of Diagnostic Products Corporation which was acquired by S… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112523 | Immulite 2000 3GALLERGY Specific Ige Assay Kit | 2012 | 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?
How does its category compare?
All DHB devicesDHB System, Test, Radioallergosorbent (Rast) Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DHB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DHB
90in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHB
14in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHB
6in 2025
MAUDE reports naming product code DHB, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 7 | 118 | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 5 | 405 | 0 | 1 |
| 2012 | 3 | 260 | 1 | 2 |
| 2013 | 5 | 257 | 0 | 0 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 1 | 11 |
| 2018 | 2 | — | 1 | 6 |
| 2019 | 3 | 90 | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 2 | — | 3 | 1 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 2 | — | 14 | 6 |
| 2026 | 6 | 138 | 0 | — |
What is it indicated for?
For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100910 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100910: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100910
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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