# K970483: Aqualite Intact PTH

- Pathway: 510(k) (Traditional)
- Applicant: Sealite Sciences, Inc.
- Decided: Apr 14, 1997 after 63 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 its predicate without a number.
- (no number) Nichols Institute Intact PTH assay: named in the summary without a submission number

## Indications for use
The AquaLite® Intact PTH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Intact PTH assay) is intended to be used in clinical laboratories for the quantitative determination of human intact parathyroid hormone in serum. Intact PTH measurements are used in the diagnosis of disorders of calcium metabolism and the parathyroid gland. The AquaLite® Intact PTH assay is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K970483
Methodology: https://510kreport.com/methodology