# K013148: Biogenex Monoclonal Anti-Estrogen Receptor (Clone ER88)

- Pathway: 510(k) (Traditional)
- Applicant: Biogenex Laboratories
- Decided: Feb 28, 2002 after 161 days
- Product code: MYA (Immunohistochemistry Antibody Assay, Estrogen 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
Longest line of descent: 2 generations back to P880026 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor, Dako Corp. (2000) Summary page 1.
- (no number) dextran-coated charcoal (DCC) technique: named in the summary without a submission number

## Indications for use
The BioGenex Mouse Monoclonal Anti-Estrogen Receptor Antibody (Clone ER88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human estrogen receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The ER88 antibody specifically binds to antigens located in the nucleus of cell populations that express estrogen receptor in normal and abnormal tissues. This antibody is indicated as an aid in assessing patient response to hormonal therapy and as an aid in the prognosis and management of breast cancer patients. 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. BioGenex ER88 antibodies have been optimally manufactured for use with BioGenex Super Sensitive MultiLink Detection Systems with or without BioGenex Automated Staining Systems.

Source page: https://510kreport.com/device/K013148
Methodology: https://510kreport.com/methodology