# K033426: Liaison N-Tact PTH

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Feb 12, 2004 after 108 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
No predicates in its family tree.
8 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) DPC Coat-A-Count® Intact PTH IRMA: named in the summary without a submission number

## Most influential descendants
- K093498: Liaison N-Tact PTH Calibration Verifiers Model 310913 (2009), 7 descendants of its own
- K132515: Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers (2013), 4 descendants of its own
- 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
- K150879: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (2015), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033426
Methodology: https://510kreport.com/methodology