# K971921: Prolactin (PRL) Hormone Microplate Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Monobind
- Decided: Jun 24, 1997 after 32 days
- Product code: CFT (Radioimmunoassay, Prolactin (Lactogen))
- Device class: 1
- Regulation: 21 CFR 862.1625
- 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) Ciba Corning ACS 180 chemiluminescence (ICMA) test: named in the summary without a submission number

## Indications for use
The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.

Source page: https://510kreport.com/device/K971921
Methodology: https://510kreport.com/methodology