# K032296: Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Aug 13, 2003 after 19 days
- Product code: JIS (Calibrator, Primary)
- 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
Longest line of descent: 2 generations back to K972133 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022901: Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators, Ortho-Clinical Diagnostics (2002) Summary page 3.

## Indications for use
VITROS Progesterone Reagent Pack For in vitro diagnostic use only. The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma. VITROS Progesterone Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).

Source page: https://510kreport.com/device/K032296
Methodology: https://510kreport.com/methodology