# K051012: Progesterone Standard Calibrator, One (1) ML of Progesterone in a Saliva-Like Matrix at a Concentration of 2430 PG/ML.

- Pathway: 510(k) (Traditional)
- Applicant: Salimetrics, LLC
- Decided: Jul 19, 2005 after 89 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The salivary progesterone calibrator is a device intended for medical purposes to use in the Salimetrics competitive enzyme immunoassay to establish points of reference that are used to determine values in the measurement of free progesterone in saliva. The salivary progesterone controls are devices intended for use in monitoring the performance of the salivary immnuoassay of free progesterone in saliva.

Source page: https://510kreport.com/device/K051012
Methodology: https://510kreport.com/methodology