# K053533: Immulite/Immulite 1000 Turbo Intact PTH

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corporation
- Decided: Feb 3, 2006 after 46 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K061190: Access Intact PTH and Calibrators, Models a 16972 and a 16953 (2006), 1 descendant of its own
- K232791: Access Intact PTH (2024), 0 descendants of its own

## Indications for use
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively.

Source page: https://510kreport.com/device/K053533
Methodology: https://510kreport.com/methodology