# K022901: Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Sep 27, 2002 after 24 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: 1 generation back to K972133 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972133: Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.C070), Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 3.

## Most influential descendants
- K032296: Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators (2003), 0 descendants of its own

## 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 a heparin).

Source page: https://510kreport.com/device/K022901
Methodology: https://510kreport.com/methodology