# K062615: Vision Biosystems Progesterone Receptor PGR Clone 16

- Pathway: 510(k) (Abbreviated)
- Applicant: Vision Biosystems, Inc.
- Decided: Jan 29, 2007 after 146 days
- Product code: MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- 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) DK Corporation Mouse Monoclonal Progesterone Receptor PgR 636: named in the summary without a submission number

## Indications for use
Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. NovocastraTm antibodies are intended for manual use. Origin Tm antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMarkTM Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits. BondTM Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max m system.

Source page: https://510kreport.com/device/K062615
Methodology: https://510kreport.com/methodology