Cleared Traditional

K013148 - BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)

K013148 is an FDA 510(k) clearance for BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEP..., manufactured by Biogenex Laboratories. The device is a Class 2 Pathology device with product code MYA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K013148 · Biogenex Laboratories · Pathology device
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Feb 2002
Decision
161d
Days
Class 2
Risk

K013148 is an FDA 510(k) clearance for the BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88). Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Biogenex Laboratories (San Ramon, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 161 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biogenex Laboratories devices

FDA 510(k) Submission Details - K013148

510(k) Number K013148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date February 28, 2002
Days to Decision 161 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 77d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYA Device Classification - Class 2, Special Controls

Product Code MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

All 10
Devices cleared under the same product code (MYA) and FDA review panel - the closest regulatory comparables to K013148.
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
K081286 · Dako North America, Inc. · May 2009
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
K061360 · Lab Vision Corp. · Jun 2006
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K060227 · Vision Biosystems, Inc. · May 2006
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · Dako Corp. · Mar 2000
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · Ventana, Inc. · Aug 1999