510(k) · Cleared
Recalled · Class II · 2020LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Jun 22, 2015 as substantially equivalent to K001411 (Scantibodies Laboratory, Inc., 2000) and 2 other predicates after an 82-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 22, 2015
- Review
- 82 days
- Class
- Class II
- Product code
- CEW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K033426 (2004). 3 ancestors in all, the oldest K001411 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033426 Liaison N-Tact PTHDiaSorin, Inc. · 2004
- 1 generation backK093498 Liaison N-Tact PTH Calibration Verifiers Model 310913DiaSorin, Inc. · 2009
- This deviceK150879 LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH…DiaSorin, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK190702 Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033426 | Liaison N-Tact PTH | DiaSorin, Inc. | 2004 | — |
| −1 | K093498 | Liaison N-Tact PTH Calibration Verifiers Model 310913 | DiaSorin, Inc. | 2009 | — |
| 0 (this device) | K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH… | DiaSorin, Inc. | 2015 | — |
| +1 | K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K001411 | Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056Summary page 4…ntial equivalence to the LIAISON® 1-84 PTH Assay is the Scantibodies Laboratory, Inc. Whole PTH™ (1-84) Specific immunoradiometric (IRMA) assay previously cleared under (K001411). The predicate device used to demonstrate substantial equivalence to the LIAISON® 1-84 PTH Control Set is the LI… | 2000 |
| * | K033426 | Liaison N-Tact PTHSummary page 5…== The predicate device used to demonstrate substantial equivalence to the LIAISON® 1-84 PTH Control Set is the LIAISON® N-TACT® PTH Control Set previously cleared under k033426. The predicate device used to demonstrate substantial equivalence to the LIAISON® 1-84 PTH Calibration Verifiers is the LIAISON®… | 2004 |
| * | K093498 | Liaison N-Tact PTH Calibration Verifiers Model 310913Summary page 5…ice used to demonstrate substantial equivalence to the LIAISON® 1-84 PTH Calibration Verifiers is the LIAISON® N-TACT® PTH Calibration Verifiers previously cleared under k093498. 7. Device Description: The LIAISON® 1-84 PTH Assay is a modified two-step, two-site sandwich assay that uses two polyclonal an… | 2009 |
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 |
|---|---|---|---|
| K190702 | Lumipulse G whole PTH | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2020 | Class II | Z-1342-2021 | Under Investigation by firm | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 5.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K190702 (Fujirebio Diagnostics,Inc., 2019) has gone furthest, with 0 descendants 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. 2015, 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 DiaSorin LIAISON® 1-84 PTH assay is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON® Analyzer. The DiaSorin LIAISON® 1-84 PTH Control Set is…
Read the full statement (123 words)
The DiaSorin LIAISON® 1-84 PTH assay is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
The test has to be performed on the LIAISON® Analyzer.
The DiaSorin LIAISON® 1-84 PTH Control Set is intended for in vitro diagnostic use as assayed quality control samples to monitor the accuracy and precision of the LIAISON® 1-84 PTH Assay.
The DiaSorin LIAISON® 1-84 PTH Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 1-84 PTH Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150879: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150879
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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