# K992105: Immulite Turbo Intact PTH, Model Lskptz

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Jul 6, 1999 after 14 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Source page: https://510kreport.com/device/K992105
Methodology: https://510kreport.com/methodology