Introduction; Purpose Statement; Intended Purpose - BD FocalPoint GS User Manual

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Introduction

This section provides introductory information about the BD FocalPoint™ GS Imaging System.
This system includes the BD FocalPoint™ Slide Profiler and the BD FocalPoint™ GS Review
Station.
1.1

Purpose Statement

The purpose of this manual is to describe the operations and functions of the BD FocalPoint™
GS Imaging System as a complete cervical cancer screening system. There are references in
this manual to individual components of the system such as the BD FocalPoint™ Slide Profiler
that, when used without the BD FocalPoint™ GS (Guided Screener) enhancement, will have
different limitations.
For more information about the performance and intended use of the BD FocalPoint™ GS
Imaging System, please see the Product Insert applicable to your region and/or contact your
BD representative
1.2

Intended Purpose

The BD FocalPoint™ GS Imaging System is comprised of the BD FocalPoint™ Slide Profiler and
the BD FocalPoint™ GS Review Station. The Intended use statements below are for the
BD FocalPoint™ Slide Profiler configured as a stand-alone product and the BD FocalPoint™
Slide Profiler configured with the BD FocalPoint™ GS Review Station, respectively.
BD FocalPoint™ Slide Profiler
The BD FocalPoint™ Slide Profiler (formerly the AutoPap System) is an automated cervical
cytology screening device intended for use in initial screening of cervical cytology slides. The
BD FocalPoint™ Slide Profiler identifies up to 25% of successfully processed slides as requiring
no further review. The BD FocalPoint™ Slide Profiler also identifies at least 15% of all
successfully processed slides for a second manual review.
The device is intended to be used on both conventionally-prepared and BD SurePath™ (formerly
AutoCyte PREP) cervical cytology slides. For both preparation methods, the device is intended
to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual
precursor conditions; it is not intended to be used on slides designated by the laboratory as
high-risk.
Intended users are trained cytology laboratory personnel operating under the direct supervision
of a qualified cytology supervisor or laboratory manager/director.
BD FocalPoint™ GS Imaging System
The BD FocalPoint™ GS Imaging System is intended to assist in cervical cancer screening of
BD SurePath™ Liquid-based Pap Test slides to detect evidence of squamous carcinoma,
adenocarcinoma and their usual precursor conditions. These slides will be ranked according to
the likelihood of abnormality, and provide relocation and visual review of up to 10 fields of view
(FOVs) most likely to contain abnormal cells. Additionally, the system identifies at least 15% of all
successfully processed slides with the BD FocalPoint™ Slide Profiler* Directed QC Technology
for a directed QC rescreen.
Intended users are trained cytology laboratory personnel operating under the direct supervision
of a qualified cytology supervisor or laboratory manager/director.
*For more information about the performance of the BD FocalPoint™ Slide Profiler, please see
the product insert document No. 500040543.
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