510(k) · Cleared
ClearedImmulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra
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 25, 2013 as substantially equivalent to K111552 (Roche Diagnostics, 2011) and 3 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Oct 25, 2013
- Review
- 25 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K950469 (1995). 10 ancestors in all, the oldest K924862 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 3 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 2 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 1 generation backK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
- This deviceK133124 Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK141444 Immulite 2000; Cortisol Calibration Verification Material, Folic…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK143687 ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK143636 IMMULITE 2000 Androstenedione Calibration Verification Material…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK143352 IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE…Siemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly3descendants
- K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly1descendant
- K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly0descendants
- K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc. · 2015 · 2 generations on0descendants
- K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −3 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −2 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −1 | K102904 | Enhanced Estradiol (EE2) Master Curve Material | Siemens Healthcare Diagnostics | 2010 | — |
| 0 (this device) | K133124 | Immulite 2000; Total T3 Calibration Verification Material, Total T4… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +1 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K141444 | Immulite 2000; Cortisol Calibration Verification Material, Folic Acid… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +2 | K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +2 | K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 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 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111552 | Elecsys T3 Calcheck 5 | 2011 |
| * | K112528 | Elecsys T4 Calcheck 5Summary page 6…ed) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys T4 CaiCheck 5 Predicate 510(k) No: K 112528 4. Device Descrntion: IMMULITE' 2000 Total T4 Calibration Verification. Material… | 2011 |
| * | K020217 | Acs:180 and Advia Centaur Ipth ImmunoassaySummary page 11…Clinical Chemistry (75) 3. Predicate Device Name ADVIA Centaur® Intact PTH Master Curve Material Predicate 510(k) No: K020217 4. Device Descrintion: IMMULITE® 2000 TBG Calibration Verification Material (CVM)… | 2002 |
| Kept off the family tree | K096429 | Elecsys FSH CalCheck Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K102904 | Enhanced Estradiol (EE2) Master Curve MaterialSummary page 21…Clinical Chemistry (75) 3. Predicate Device Name ADVIA Centaur& Enhanced Estradiol (eE2) MCM Predicate 510(k) No: K 102904 4. Device Descrintilon: IMMULITE® 2000 Estradiol Calibration Verification Material… | 2010 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration… | 2014 | 3 |
| K141444 | Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration… | 2014 | 1 |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur… | 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?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K140818 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K111552.
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 Total T3 Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T3 assay on the IMMULITE 2000 systems. The IMMULITE Total T4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T4 assay on the IMMULITE 2000 systems. The IMMULITE TBG Calibration Verification Material (CVM) is for in…
Read the full statement (145 words)
The IMMULITE Total T3 Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T3 assay on the IMMULITE 2000 systems.
The IMMULITE Total T4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T4 assay on the IMMULITE 2000 systems.
The IMMULITE TBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE TBG assay on the IMMULITE 2000 systems.
The IMMULITE FSH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE FSH assay on the IMMULITE 2000 systems.
The IMMULITE Estradiol Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Estradiol assay on the IMMULITE 2000 systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133124
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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