# K972761: Sealite Sciences, Inc. Aqualite Human Growth Hormone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sealite Sciences, Inc.
- Decided: Sep 25, 1997 after 63 days
- Product code: CFL (Radioimmunoassay, Human Growth Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1370
- 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 Human Growth Hormone Assay: named in the summary without a submission number

## Indications for use
The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative measurement of growth hormone in human serum. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

Source page: https://510kreport.com/device/K972761
Methodology: https://510kreport.com/methodology