510(k) · Cleared
ClearedImmulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C
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 Apr 1, 2014 as substantially equivalent to K133128 (Siemens Healthcare Diagnostics, Inc., 2013) after a 28-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 1, 2014
- Review
- 28 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950469 (1995). 16 ancestors in all, the oldest K910440 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 5 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 4 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 3 generations backK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
- 2 generations backK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
- 1 generation backK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- This deviceK140541 Immulite 2000: C-Peptide Calibration Verification Material, SHBG…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK143373 IMMULITE® 2000 Calcitonin Calibration Verification Material…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK143504 IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE…Siemens Healthcare Diagnostics, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See all- K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly0descendants
- K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens 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 |
|---|---|---|---|---|---|
| −6 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −5 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −4 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −3 | K102904 | Enhanced Estradiol (EE2) Master Curve Material | Siemens Healthcare Diagnostics | 2010 | — |
| −2 | K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification Material | Siemens Healthcare Diagnostics | 2011 | — |
| −1 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K140541 | Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +1 | K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Summary page 1…vice Name IMMULITE® 2000 Growth Hormone Calibration Verification Material (CVM) Predicate 510(k) No: K133 128 4. Device Description: The C-Peptide Calibration Verification Material (CVM) contains one set of f… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K143373 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K133128.
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. 2014, 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® C-Peptide Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems.
The IMMULITE® SHBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems.
The IMMULITE® Total Testosterone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140541
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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