510(k) · Cleared
ClearedImmulite 2000 Systems 3GALLERGY Specific Ige Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on May 28, 2014 as substantially equivalent to K112523 (Siemens Healthcare Diagnostics, Inc., 2012) after a 257-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- May 28, 2014
- Review
- 257 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911511 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK911511 Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp. · 1991
- 3 generations backK013134 Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel…Diagnostic Products Corp. · 2001 · Recalled
- 2 generations backK093987 Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc. · 2011
- 1 generation backK112523 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc. · 2012
- This deviceK132801 Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911511 | Alastat Allergen Specified Ige System, Modified | Diagnostic Products Corp. | 1991 | — |
| −3 | K013134 | Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600… | Diagnostic Products Corp. | 2001 | 2 |
| −2 | K093987 | Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6 | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
| −1 | K112523 | Immulite 2000 3GALLERGY Specific Ige Assay Kit | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K112523 | Immulite 2000 3GALLERGY Specific Ige Assay KitSummary page 1…FDA clearance was previously obtained for the assay kit and I111 specific allergens (K093987, K 100910, KI 01572 and K 112523). 5. Device Description: IMMULITE® 2000 3gAllergyTM Specific IgE Universal Kit… | 2012 |
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 23 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 4 of the 9 ancestors have a recall of any class.
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. 2014, 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?
The 3gAllergy Specific IgE Universal Kit is 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/K132801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132801: Immulite 2000 Systems 3GALLERGY Specific 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/K132801
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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