510(k) · Cleared
ClearedImmulite 2000 3GALLERGY Specific Ige Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Aug 6, 2009 as substantially equivalent to K013134 (Diagnostic Products Corp., 2001) and 3 other predicates after a 97-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 6, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K911511 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK911511 Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp. · 1991
- 1 generation backK013134 Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel…Diagnostic Products Corp. · 2001 · Recalled
- This deviceK091289 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911511 | Alastat Allergen Specified Ige System, Modified | Diagnostic Products Corp. | 1991 | — |
| −1 | K013134 | Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600… | Diagnostic Products Corp. | 2001 | 2 |
| 0 (this device) | K091289 | Immulite 2000 3GALLERGY Specific Ige Assay Kit | Siemens Healthcare Diagnostics | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013134 | Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)Summary page 2…W82 Careless Weed 6 W37 Saltbush FDA clearance was previously obtained for the assay kit and 196 specific allergens and allergen panels (K013134, K021206, K013135 and K021208). Please note that the FDA clearances indicated above were in the name of Diagnostic Products Corpo… | 2001 |
| * | K021206 | Immulite 2000 Specific AllergensSummary page 2…less Weed 6 W37 Saltbush FDA clearance was previously obtained for the assay kit and 196 specific allergens and allergen panels (K013134, K021206, K013135 and K021208). Please note that the FDA clearances indicated above were in the name of Diagnostic Products Corporation wh… | 2002 |
| * | K013135 | Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)Summary page 2…6 W37 Saltbush FDA clearance was previously obtained for the assay kit and 196 specific allergens and allergen panels (K013134, K021206, K013135 and K021208). Please note that the FDA clearances indicated above were in the name of Diagnostic Products Corporation which was a… | 2001 |
| * | K021208 | Immulite 2000 Mixed Allergen PanelsSummary page 2…6 W37 Saltbush FDA clearance was previously obtained for the assay kit and 196 specific allergens and allergen panels (K013134, K021206, K013135 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?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 7 other devices also cite its predicate K013134.
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. 2009, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091289: Immulite 2000 3GALLERGY Specific Ige Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091289
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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