# K103818: Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Sytems, Inc.
- Decided: Nov 16, 2011 after 322 days
- Product code: MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P900013 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining, Dako Corp. (2002) Summary page 1.

## Recalls of this device
- Aug 2, 2018 · Class I · Z-3006-2018: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

## Indications for use
This antibody is intended for in vitro diagnostic (IVO) use. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PIR positive normal and neoplastic cells. CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. Prescription use only.

Source page: https://510kreport.com/device/K103818
Methodology: https://510kreport.com/methodology