510(k) · Cleared
ClearedLiaison N-Tact PTH Gen II, Control Set, 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 Nov 8, 2013 as substantially equivalent to K020217 (Bayer Diagnostics Corp., 2002) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Nov 8, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954418 (1995). 4 ancestors in all. 4 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 backK020217 Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 2002 · Recalled
- This deviceK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK173683 LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN…DiaSorin, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014 · cites it directly3descendants
- K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc. · 2018 · 2 generations on1descendant
- K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · 3 generations on0descendants
- K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…DiaSorin, Inc. · 2018 · 2 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 | K020217 | Acs:180 and Advia Centaur Ipth Immunoassay | Bayer Diagnostics Corp. | 2002 | 4 |
| 0 (this device) | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers | DiaSorin, Inc. | 2013 | — |
| +1 | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | DiaSorin, Inc. | 2014 | — |
| +2 | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin… | DiaSorin, Inc. | 2018 | — |
| +3 | K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | 2022 | 1 |
| +2 | K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS… | DiaSorin, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K020217 | Acs:180 and Advia Centaur Ipth ImmunoassaySummary page 1…d to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen 11is the Siemens ADVIA® CENTAUR INTACT Parathyroid Hormone (iPTH) Assay previously cleared under k020217. The predicate device used to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen 11Control Set i… | 2002 |
| * | K033426 | Liaison N-Tact PTHSummary page 2…edicate device used to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen 11Control Set is the LIAISON® N-TACT® PTH Control Set previously cleared under k033426. The predicate device used to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen 11Calibration Verifiers is the… | 2004 |
| * | K093498 | Liaison N-Tact PTH Calibration Verifiers Model 310913Summary page 2…to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen 11Calibration Verifiers is the LIAISON® N-TACT® PTH Calibration Verifiers previously cleared under k093498. 7. Device Description: The LIAISON® N-TACT® PTH Gen 11assay is a modified two-step, two-site sandwich assay that uses two goat… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | 2014 | 3 |
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 18 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K141463 (DiaSorin, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K020217.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 LIAISON N-TACT PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON XL analyzer. The LIAISON N-TACT PTH Gen…
Read the full statement (126 words)
The LIAISON N-TACT PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON XL analyzer.
The LIAISON N-TACT PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON N-TACT PTH Gen II assay.
The LIAISON N-TACT PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON N-TACT PTH Gen II assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132515: Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132515
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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