# K132515: Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Nov 8, 2013 after 88 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954418 (1995). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020217: Acs:180 and Advia Centaur Ipth Immunoassay, Bayer Diagnostics Corp. (2002) Summary page 1.
- K033426: Liaison N-Tact PTH, DiaSorin, Inc. (2004) Summary page 2.
- K093498: Liaison N-Tact PTH Calibration Verifiers Model 310913, DiaSorin, Inc. (2009) Summary page 2.

## Most influential descendants
- K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers (2014), 3 descendants of its own
- K182698: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (2018), 1 descendant of its own
- K213858: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (2022), 0 descendants of its own
- K173683: LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K132515
Methodology: https://510kreport.com/methodology