# K150879: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jun 22, 2015 after 82 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033426 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001411: Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056, Scantibodies Laboratory, Inc. (2000) Summary page 4.
- K033426: Liaison N-Tact PTH, DiaSorin, Inc. (2004) Summary page 5.
- K093498: Liaison N-Tact PTH Calibration Verifiers Model 310913, DiaSorin, Inc. (2009) Summary page 5.

## Most influential descendants
- K190702: Lumipulse G whole PTH (2019), 0 descendants of its own

## Recalls of this device
- Nov 23, 2020 · Class II · Z-1342-2021: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.

## Indications for use
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.

Source page: https://510kreport.com/device/K150879
Methodology: https://510kreport.com/methodology