# K103325: Ids-Isys Intact PTH

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Feb 3, 2012 after 448 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161158: IDS-iSYS Intact PTHN (2017), 0 descendants of its own

## Indications for use
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemnia and hypocalcemia resulting from disorders of calcium metabolism. The kit is for in vitro diagnostic use only. The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the precision of the IDS-iSYS Intact PTH assay. The IDS-iSYS Intact PTH Calibrator is intended for the calibration of the IDS-iSYS Intact PTH assay. The IDS-iSYS iPTIH Calibration Verifier is intended for verification of calibration of the IDS-iSYS iPTH Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Source page: https://510kreport.com/device/K103325
Methodology: https://510kreport.com/methodology