510(k) · Cleared
ClearedAdvia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material
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 Mar 31, 2014 as substantially equivalent to K060755 (Roche Diagnostics Corp., 2006) and 2 other predicates after a 32-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it.
- Decided
- Mar 31, 2014
- Review
- 32 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K924862 (1992). 11 ancestors in all, the oldest K924863 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 3 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 2 generations backK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- 1 generation backK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- This deviceK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK191533 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK190121 Ids SHBGImmunodiagnostic Systems, Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2016 · cites it directly2descendants
- K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019 · 2 generations on0descendants
- K190121Ids SHBGImmunodiagnostic Systems, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −3 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +2 | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
| +2 | K190121 | Ids SHBG | Immunodiagnostic Systems, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckSummary page 1…sayed) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys Vitamin B812 CalCheck Predicate 510(k) No: K060755 4. Device Description: ADVIA Centauro Vitamin 81 2 Master Curve Material is an… | 2006 |
| * | K092168 | Elecsys HCG+B Calcheck 5Summary page 7…) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys HCG CalCheck 5 Predicate 510(k) No: K092 168 4. Device Description: ADVIA Centaur® ThCG Master Curve Materials is an in vitro… | 2009 |
| * | K970146 | Elecsys Calcheck TestosteroneSummary page 13…anel: Clinical Chemistry (75) 3. Predicate Device Name Eleesys Testosterone CalCheck Predicate 510(k) No: K970146 4. Device Description: ADVIA Centaur® TSTO Master Curve Materials is an in vitro… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve… | 2016 | 2 |
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 22 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K151986 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K060755.
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 ADVIA Centaur Vitamin B12 (VB12) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay.
The ADVIA Centaur Total hCG (ThCG) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
The ADVIA Centaur Testosterone (TSTO) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Testosterone assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140505
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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