510(k) · Cleared
Recalled · Class II · 2013Advia Centaur Inact Parathyroid Hormone (Ipth) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Mar 21, 2013 as substantially equivalent to K063232 (Biokit, S.A., 2007) after a 258-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 21, 2013
- Review
- 258 days
- Class
- Class II
- Product code
- CEW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954418 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 2 generations backK992680 Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. · 1999 · Recalled
- 1 generation backK063232 Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low…Biokit, S.A. · 2007 · Recalled
- This deviceK121981 Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics · 2013
- Descendant · cites it directly · 1 of its ownK133601 Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK163658 ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −2 | K992680 | Elecsys Parathyroid Hormone Test System | Roche Diagnostics Corp. | 1999 | 1 |
| −1 | K063232 | Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium… | Biokit, S.A. | 2007 | 4 |
| 0 (this device) | K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) Assay | Siemens Healthcare Diagnostics | 2013 | — |
| +1 | K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) Assay | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 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 CEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEW device
- #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K063232 | Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High)…Summary page 1…Panel: Clinical Chemistry F. Predicate Device: The ADVIA® Centaur iPTH Assay is substantially equivalent to the Abbott Architect Intact PTH Assay cleared under 51 0(k) k063232 G. Device Description: The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technol… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) Assay | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2013 | Class II | Z-1513-2013 | No Marketing Application | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability |
| May 14, 2013 | Class II | Z-1512-2013 | No Marketing Application | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K133601 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CEW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEW
160in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEW
37in 2025
MAUDE reports naming product code CEW, 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 | 4 | 160 | 1 | 0 |
| 2008 | 0 | — | 1 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 3 | 23 |
| 2011 | 0 | — | 0 | 97 |
| 2012 | 1 | — | 0 | 124 |
| 2013 | 2 | — | 1 | 172 |
| 2014 | 1 | — | 0 | 167 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 0 | — | 2 | 98 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 65 |
| 2019 | 1 | — | 0 | 77 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 2 | 188 |
| 2023 | 1 | — | 0 | 82 |
| 2024 | 2 | — | 2 | 67 |
| 2025 | 0 | — | 1 | 37 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121981: Advia Centaur Inact Parathyroid Hormone (Ipth) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121981
Report an extraction error
Are you the manufacturer?
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