# K990618: Ventana PGR Primary Antibody (Clone 1A6)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Jul 23, 1999 after 148 days
- Product code: MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P920006 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P920006: Immunocytochemical Assay to Detect Progesterone, Abbott Laboratories (1995) Summary page 5.

## Most influential descendants
- K061360: Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1) (2006), 0 descendants of its own
- K012960: Biogenex Monoclonal Anti-Progesterone Receptor (2002), 0 descendants of its own

## Recalls of this device
- May 16, 2011 · Not classified · Z-2717-2011: The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection K
- May 16, 2011 · Not classified · Z-2716-2011: The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection K

## Indications for use
Ventana Medical Systems’ PGR Primary Antibody (Clone 1A6) may be used in immunohistochemical methods to aid in the identification of progesterone receptor (PGR) antigen in normal and neoplastic cells as an aid in the diagnosis of PGR positive tumors. The anti-PGR is intended for laboratory use to qualitatively stain PGR antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. Detection chemistries used by Ventana to detect PGR are DAB, AEC, Alkaline phosphatase red and blue. Light microscopy is used to detect the staining of cell components. It is indicated for use as an aid in the management, prognosis and prediction of therapy outcome of breast cancer.

Source page: https://510kreport.com/device/K990618
Methodology: https://510kreport.com/methodology