510(k) · Cleared
Recalled · Class II · 2019Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Jun 19, 2007 as substantially equivalent to K992680 (Roche Diagnostics Corp., 1999) after a 237-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 19, 2007
- Review
- 237 days
- Class
- Class II
- Product code
- CEW
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954418 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 1 generation backK992680 Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. · 1999 · Recalled
- This deviceK063232 Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low…Biokit, S.A. · 2007
- Descendant · cites it directly · 2 of its ownK121981 Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK133601 Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK163658 ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics · 2013 · cites it directly2descendants
- K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on1descendant
- K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −1 | K992680 | Elecsys Parathyroid Hormone Test System | Roche Diagnostics Corp. | 1999 | 1 |
| 0 (this device) | K063232 | Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium… | Biokit, S.A. | 2007 | — |
| +1 | K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) Assay | Siemens Healthcare Diagnostics | 2013 | 2 |
| +2 | K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) Assay | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +3 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K992680 | Elecsys Parathyroid Hormone Test SystemSummary page 2…age I of'3 510k Submission 510kSummary Final Legally marketed device to which equivalency is claimed: The ROCHE® Elecsys Parathyroid Hormone Test System (K992680) is used as the predicate device. Intended Use of Device: The ARCHITECT® Intact PTH assay is an in vitro chemiluminescent micro… | 1999 |
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 |
|---|---|---|---|
| K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) Assay | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2019 | Class III | Z-1358-2019 | Under Investigation by firm | Devices were delivered without the required dry ice. |
| Apr 9, 2019 | Class III | Z-1357-2019 | Under Investigation by firm | Devices were delivered without the required dry ice. |
| Feb 12, 2014 | Class II | Z-1672-2014 | Under Investigation by firm | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to… |
| Feb 12, 2014 | Class II | Z-1671-2014 | Under Investigation by firm | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K121981 (Siemens Healthcare Diagnostics, 2013) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K992680.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders. The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT i System…
Read the full statement (117 words)
The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders.
The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.
The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063232: Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063232
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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