510(k) · Cleared
ClearedADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on May 23, 2017 as substantially equivalent to K133601 (Siemens Healthcare Diagnostics, Inc., 2014) after a 151-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- May 23, 2017
- Review
- 151 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954418 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 4 generations backK992680 Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. · 1999 · Recalled
- 3 generations backK063232 Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low…Biokit, S.A. · 2007 · Recalled
- 2 generations backK121981 Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics · 2013 · Recalled
- 1 generation backK133601 Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc. · 2014
- This deviceK163658 ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −4 | K992680 | Elecsys Parathyroid Hormone Test System | Roche Diagnostics Corp. | 1999 | 1 |
| −3 | K063232 | Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium… | Biokit, S.A. | 2007 | 4 |
| −2 | K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) Assay | Siemens Healthcare Diagnostics | 2013 | 2 |
| −1 | K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) Assay | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| 0 (this device) | K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySummary page 4…Predicate Device Information ADVIA Centaur Intact Parathyroid Hormone (iPTH) Predicate Device Name: ADVIA Centaur Intact Parathyroid Hormone (iPTH) 510(k) Number: K133601 5. Intended Use / Indications for Use ADVIA Centaur Intact Parathyroid Hormone (PTH) The ADVIA Centaur Intact Parathyro… | 2014 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or disorders of calcium metabolism. This assay can be used intra-operatively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163658: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163658
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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