510(k) · Cleared
Recalled · Class II · 2022IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JZO System, Test, Thyroid Autoantibody
Cleared on Mar 3, 2016 as substantially equivalent to K092229 (Diagnostic Hybrids, Inc., 2010) and 2 other predicates after a 223-day review. Its family tree reaches back 5 generations to 2000. It has been recalled once.
- Decided
- Mar 3, 2016
- Review
- 223 days
- Class
- Class II
- Product code
- JZO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001015 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 4 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 3 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 2 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 1 generation backK080643 Elecsys Anti-TSHR CalcheckRoche Diagnostics · 2008
- This deviceK152061 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −4 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −3 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −2 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −1 | K080643 | Elecsys Anti-TSHR Calcheck | Roche Diagnostics | 2008 | — |
| 0 (this device) | K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 JZO? 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 JZO device
- #1 K250250 ADVIA Centaur Anti-Thyroid Peroxidase IIscore 10.5 · 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? (3)
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 |
|---|---|---|---|
| * | K092229 | Thyretain TM Tsi Reporter BioassaySummary page 5…ting MAb (M22) • Multi-Diluent 2 J. Substantial Equivalence Information: 1. Predicate device names(s) and 510(k) number(s): Thyretain TSI Reporter BioAssay, k092229 Elecsys Anti-TSHR Immunoassay, k080092 Elecsys Anti-TSHR CalCheck, k080643 2. Comparison with predicate:… | 2010 |
| * | K080092 | Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol ThyroabSummary page 5…antial Equivalence Information: 1. Predicate device names(s) and 510(k) number(s): Thyretain TSI Reporter BioAssay, k092229 Elecsys Anti-TSHR Immunoassay, k080092 Elecsys Anti-TSHR CalCheck, k080643 2. Comparison with predicate: ASSAY SIMILARITIES – Pred… | 2008 |
| * | K080643 | Elecsys Anti-TSHR CalcheckSummary page 5…icate device names(s) and 510(k) number(s): Thyretain TSI Reporter BioAssay, k092229 Elecsys Anti-TSHR Immunoassay, k080092 Elecsys Anti-TSHR CalCheck, k080643 2. Comparison with predicate: ASSAY SIMILARITIES – Predicate 1 Item… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2022 | Class II | Z-1820-2022 | Under Investigation by firm | An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JZO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JZO
Too few JZO 510(k)s in any year since 2007 to give a median.
Recalls per year · JZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JZO
44in 2025
MAUDE reports naming product code JZO, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 29 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMULITE® 2000 TSI (thyroid-stimulating immunoglobulins) Assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of thyroid stimulating autoantibodies specific to thyroid stimulating hormone receptors (TSHR) in human serum (including Serum Separator tubes) or plasma (K2-EDTA or lithium heparin). The IMMULITE® 2000 TSI Assay is for use on the IMMULITE® 2000 system. The measurement of thyroid stimulating autoantibodies, in…
Read the full statement (111 words)
The IMMULITE® 2000 TSI (thyroid-stimulating immunoglobulins) Assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of thyroid stimulating autoantibodies specific to thyroid stimulating hormone receptors (TSHR) in human serum (including Serum Separator tubes) or plasma (K2-EDTA or lithium heparin). The IMMULITE® 2000 TSI Assay is for use on the IMMULITE® 2000 system. The measurement of thyroid stimulating autoantibodies, in conjunction with other clinical and laboratory findings, is used as an aid in the diagnosis of patients suspected of having Graves' disease.
The IMMULITE® TSI Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE® TSI Assay on the IMMULITE® 2000 Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152061: IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152061
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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