510(k) · Cleared
ClearedImmulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige Control Verification Material (CVM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Oct 30, 2013 as substantially equivalent to K102269 (Roche Diagnostics, 2010) after a 30-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- Oct 30, 2013
- Review
- 30 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102269 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK102269 Elecsys Ige Calcheck 5Roche Diagnostics · 2010
- This deviceK133122 Immulite 2000; 3GALLERGY Specific Ige Control Verification Material…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK143680 ADVIA Centaur IgE Master Curve MaterialSiemens Healthcare Diagnostics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143680ADVIA Centaur IgE Master Curve MaterialSiemens Healthcare Diagnostics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102269 | Elecsys Ige Calcheck 5 | Roche Diagnostics | 2010 | — |
| 0 (this device) | K133122 | Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM)… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +1 | K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 JJX? 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? (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 |
|---|---|---|---|
| * | K102269 | Elecsys Ige Calcheck 5Summary page 2…98% sodium azide and preservatives. J. Substantial Equivalence Information: Predicate Device name: Eleesys IgE CalCheck 5 Predicate 510(k) number: k 102269 Comparison with predicate: A comparison of the device features, intended use, and other information demonstrates… | 2010 |
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 |
|---|---|---|---|
| K143680 | ADVIA Centaur IgE Master Curve Material | 2015 | 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?
- Its one ancestor has no recall.
- Of its descendants, K143680 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.
The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133122: Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige Control Verification Material (CVM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133122
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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