# K970915: DSL Estrone-Sulfate Ria

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: May 16, 1997 after 65 days
- Product code: CGF (Radioimmunoassay, Estrone)
- Device class: 1
- Regulation: 21 CFR 862.1280
- 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) DSL 8700 Estrone RIA: named in the summary without a submission number

## Indications for use
The DSL 5400 Estrone-Sulfate RIA assay is intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.

Source page: https://510kreport.com/device/K970915
Methodology: https://510kreport.com/methodology