510(k) · Cleared
ClearedLiaison N-Tact PTH
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 Feb 12, 2004 after a 108-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 12, 2004
- Review
- 108 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK033426 Liaison N-Tact PTHDiaSorin, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK093498 Liaison N-Tact PTH Calibration Verifiers Model 310913DiaSorin, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK150879 LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH…DiaSorin, Inc. · 2015 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093498Liaison N-Tact PTH Calibration Verifiers Model 310913DiaSorin, Inc. · 2009 · cites it directly7descendants
- K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013 · cites it directly4descendants
- K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014 · 2 generations on3descendants
- K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc. · 2018 · 3 generations on1descendant
- K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033426 | Liaison N-Tact PTH | DiaSorin, Inc. | 2004 | — |
| +1 | K093498 | Liaison N-Tact PTH Calibration Verifiers Model 310913 | DiaSorin, Inc. | 2009 | — |
| +1 | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers | DiaSorin, Inc. | 2013 | — |
| +2 | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | DiaSorin, Inc. | 2014 | — |
| +3 | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin… | DiaSorin, Inc. | 2018 | — |
| +1 | K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH… | DiaSorin, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | — | DPC Coat-A-Count® Intact PTH IRMA Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K093498 (DiaSorin, Inc., 2009) has gone furthest, with 7 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.
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® Control N-tact PTH is intended for use as assayed quality control materials to monitor the accuracy and precision of the LIAISON® N-tact PTH immunoassay.
The LIAISON® N-tact™ PTH is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033426 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033426: Liaison N-Tact PTH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033426
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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