Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K130861 ↗

FDA Product Code

MXZ

Device Class

Class II

Regulation

21 CFR Part 864.1860

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

  Class II

  FDA 510(k) K160922 Active Cleared 3 May 2016

• Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone Epi

  Class II

  FDA 510(k) K120663 Active Cleared 12 Feb 2013

• Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634

  Class II

  FDA 510(k) K081286 Active Cleared 8 May 2009

• PD-L1 IHC 28-8 pharmDx

  Class III

  FDA PMA P150027 Active Approved 23 Jan 2016

• C-Kit PharmDx Immunohistochemistry Antibody Assay

  Class III

  FDA PMA P040011 Withdrawn Approved 27 Jun 2005

• What is the primary clinical use of this monoclonal antibody in pathology diagnostics?

  This antibody is designed specifically to detect human progesterone receptors in formalin-fixed, paraffin-embedded tissue samples. It enables pathologists to visualize and assess the presence and semi-quantitative levels of progesterone receptor expression, which is critical for evaluating hormone receptor status in cancer tissue—particularly in breast and other hormone-sensitive cancers—within hematology and pathology diagnostics.

• How is this antibody supplied, and what systems is it compatible with for staining?

  The antibody is supplied as a ready-to-use reagent, eliminating the need for dilution or preparation by the user. It is intended for use exclusively with automated staining systems, such as the Autostainer Link, ensuring consistent and standardized immunohistochemical staining in laboratory settings.

• Is this antibody sterile and suitable for direct patient use, or is it intended solely for laboratory diagnostics?

  This antibody is not sterile for surgical or invasive procedures and is not intended for direct patient use. It is packaged for laboratory diagnostics under controlled conditions, meaning it is designed for use in pathology labs to analyze tissue samples—never for clinical administration or patient contact.

• What regulatory pathway was followed for this device’s clearance, and which advisory committee reviewed it?

  This device received FDA 510(k) clearance under the classification of an Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ). The review was conducted by the Pathological Devices (PA) Panel of the Hematology Expert Panel (HE), with a decision of Substantially Equivalent (SESE) to a predicate device, as documented in the 510(k) submission.

• Are there any specific storage or handling requirements mentioned for this antibody?

  While the provided data does not specify exact storage conditions, as a ready-to-use laboratory reagent, it should be stored according to standard protocols for immunohistochemistry antibodies—typically refrigerated (2–8°C) and protected from light. Always refer to the manufacturer’s instructions for precise handling, as improper storage could compromise its performance in detecting progesterone receptors.