510(k) · Cleared
Recalled · Class II · 2024Access Intact PTH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Mar 1, 2024 as substantially equivalent to K061190 (Beckman Coulter, Inc., 2006) after a 172-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Mar 1, 2024
- Review
- 172 days
- Class
- Class II
- Product code
- CEW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954418 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 backK061190 Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc. · 2006 · Recalled
- This deviceK232791 Access Intact PTHBeckman Coulter, Inc. · 2024
View 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 | K061190 | Access Intact PTH and Calibrators, Models a 16972 and a 16953 | Beckman Coulter, Inc. | 2006 | 1 |
| 0 (this device) | K232791 | Access Intact PTH | Beckman Coulter, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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
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 |
|---|---|---|---|
| * | K061190 | Access Intact PTH and Calibrators, Models a 16972 and a 16953Summary page 4…PTH Common Name: Parathyroid Hormone Test Classification Regulation: 21 CFR 862.1545 Classification Product Code: CEW Predicate Device: Access Intact PTH 510(k) Number K061190 Device Description The Access Intact PTH assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2024 | Class II | Z-0673-2025 | Process design | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 4 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. 2024, 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 Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
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/K232791 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232791: Access Intact PTH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232791
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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