510(k) · Cleared
ClearedADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 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 Jul 17, 2015 as substantially equivalent to K133124 (Siemens Healthcare Diagnostics, Inc., 2013) and 3 other predicates after a 205-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 17, 2015
- Review
- 205 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K950469 (1995). 24 ancestors in all, the oldest K910440 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 6 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 5 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 4 generations backK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
- 3 generations backK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
- 2 generations backK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- 1 generation backK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
- This deviceK143687 ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −6 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −5 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −4 | K102904 | Enhanced Estradiol (EE2) Master Curve Material | Siemens Healthcare Diagnostics | 2010 | — |
| −3 | K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification Material | Siemens Healthcare Diagnostics | 2011 | — |
| −2 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| −1 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| 0 (this device) | K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K133124 | Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Summary page 7…(75) 3. Predicate Device Name IMMULITE 2000 FSH Calibration Verification Material (CVM) Predicate 510(k) No: k133124 4. Device Description: ADVIA Centaur® FSH Master Curve Material is an in vitro di… | 2013 |
| * | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Summary page 13…Clinical Chemistry (75) 3. Predicate Device Name IMMULITE 2000 FT4 Calibration Verification Material (CVM) Predicate 510(k) No: k140818 4. Device Description: ADVIA Centaur® FT4 Master Curve Material is an in vitro… | 2014 |
| * | K112528 | Elecsys T4 Calcheck 5Summary page 19…d) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys T4 Calcheck 5 Predicate 510(k) No: k112528 4. Device Description: ADVIA Centaur® T4 Master Curve Material is an in vitro… | 2011 |
| * | K111552 | Elecsys T3 Calcheck 5Summary page 25…d) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys T3 Calcheck 5 Predicate 510(k) No: k111552 4. Device Description: ADVIA Centaur® T3 Master Curve Material is an in vitro… | 2011 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 24 ancestors has a recall of any class.
- 2 other devices also cite its predicate K133124.
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. 2015, 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® Follicle Stimulating Hormone (FSH) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FSH assay. The ADVIA Centaur® Free thyroxine (FT4) Master Curve Material 1s for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FT4 assay. The ADVIA Centaur® Thyroxine (T4) Master Curve Material is for in vitro diagnostic…
Read the full statement (115 words)
The ADVIA Centaur® Follicle Stimulating Hormone (FSH) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FSH assay.
The ADVIA Centaur® Free thyroxine (FT4) Master Curve Material 1s for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FT4 assay.
The ADVIA Centaur® Thyroxine (T4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T4 assay.
The ADVIA Centaur® Triiodothyronine (T3) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T3 assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143687: ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 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/K143687
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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