510(k) · Cleared
Recalled · Class II · 2024Access Intact PTH and Calibrators, Models a 16972 and a 16953
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 Sep 15, 2006 as substantially equivalent to K992680 (Roche Diagnostics Corp., 1999) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 15, 2006
- Review
- 140 days
- Class
- Class II
- Product code
- CEW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954418 (1995). 3 ancestors in all. 1 later device descends 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 deviceK061190 Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK232791 Access Intact PTHBeckman Coulter, Inc. · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K232791Access Intact PTHBeckman Coulter, Inc. · 2024 · cites it directly0descendants
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) | K061190 | Access Intact PTH and Calibrators, Models a 16972 and a 16953 | Beckman Coulter, Inc. | 2006 | — |
| +1 | K232791 | Access Intact PTH | Beckman Coulter, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 7.7 · 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? (2)
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 1…ice(s) Elecsys Parathyroid Hormone Test System Roche Diagnostics Corporation 9115 Hague Rd Indianapolis, IN46250 510(k) Number: k992680 Immulite®/Immulite® 1000 Turbo Intact PTH Diagnostic Products Corporation Corporate Offices 521… | 1999 |
| * | K053533 | Immulite/Immulite 1000 Turbo Intact PTHSummary page 1…ct PTH Diagnostic Products Corporation Corporate Offices 521 0 Pacific Concourse Drive Los Angeles, CA 90045-6900 510(k) Number: k053533 Device Description The Access Intact PTH reagents, calibrators, and the Access Immunoa… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232791 | Access Intact PTH | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 26, 2024 | Class II | Z-0803-2025 | Nonconforming Material/Component | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K232791 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 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.
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…
Read the full statement (109 words)
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.
The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061190: Access Intact PTH and Calibrators, Models a 16972 and a 16953.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061190
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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