510(k) · Cleared
ClearedImmulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB Calibration Verificatin Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Helathcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Sep 20, 2013 as substantially equivalent to K020369 (Roche Diagnostics Corp., 2002) and 2 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Sep 20, 2013
- Review
- 50 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K924862 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 2 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 1 generation backK020369 Elecsys Anti-TG CalcheckRoche Diagnostics Corp. · 2002
- This deviceK132391 Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite…Siemens Helathcare Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −2 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K020369 | Elecsys Anti-TG Calcheck | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K132391 | Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000… | Siemens Helathcare Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K020369 | Elecsys Anti-TG CalcheckSummary page 1…d) Panel: Clinical Chemistry (75) 3. Predicate Device Name Eleesys Anti-TO Caliheck Predicate 510(k) No: K020369 4. Device Description: The Calibration Verification Material (CVM) contains one set of… | 2002 |
| * | K001014 | Elecsys Anti-Tpo CalcheckSummary page 5…) Panel: Clinical Chemistry (75) 3. Predicate Device Name Eleesys Anti-TPO CalCheck Predicate 510(k) No: K001014 4. Device Description: The Calibration Verification Material (CVM) contains one set of… | 2000 |
| * | K020217 | Acs:180 and Advia Centaur Ipth ImmunoassaySummary page 9…Clinical Chemistry (75) 3. Predicate Device Name ADVIA Centaur@ Intact PTH Master Curve Material (MCM) Predicate 510(k) No: K0202 17 4. Device Description: The Calibration Verification Material (C VM),contains one set of… | 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 21 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
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® Anti-TO Ab Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Thyroglobulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Thyroglobulin assay on the IMMULITE 2000 systems as indicated in the CVM…
Read the full statement (109 words)
The IMMULITE® Anti-TO Ab Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert.
The IMMULITE® Thyroglobulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Thyroglobulin assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert.
The IMMULITE® Anti-TPO All Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TPO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132391: Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB Calibration Verificatin Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132391
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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