AUTOPAP 300 QC SYSTEM

JSON twin: https://www.healthaidb.com/software/autopap-300-qc-system.json

Company Name

BD DIAGNOSTICS

Product URL

https://www.bd.com/en-us/offerings/capabilities/diagnostics/clinical-chemistry/hematology/hematology-instruments/hematology-instruments-detail.page?prod=AUTOPAP+%28R%29+300+QC+AUTOMATIC+PAP+SCREENER%2FQC+SYSTEM

Company URL

https://www.bd.com/en-us

Categories

• diagnostic Support
• clinical Care
• laboratory Testing
• administrative Operations
• quality & Safety
• Diagnostic
• Clinical
• Laboratory
• Automation
• Quality Control

Summary

The AUTOPAP 300 QC SYSTEM is an automated cervical cytology screening device designed to enhance the detection of cervical abnormalities by rescreening Pap smear slides, thereby improving diagnostic accuracy and laboratory efficiency.

Description

The AUTOPAP 300 QC SYSTEM is an automated device developed by BD Diagnostics for the analysis of conventional cervical cytology slides. It identifies slides requiring further review, thereby enhancing the detection of cervical abnormalities and improving laboratory efficiency. The system has been FDA-approved for both conventional smears and BD SurePath Pap tests. It operates by scanning slides at varying objective levels, assigning scores based on cellular characteristics, and integrating these scores into a final slide score indicating the likelihood of significant epithelial abnormalities. The device can identify up to 25% of processed slides as requiring no further review and at least 15% for a second manual review. It is intended for use by trained cytology laboratory personnel under the supervision of a qualified cytology supervisor or laboratory manager/director. The AUTOPAP 300 QC SYSTEM has been evaluated in multiple clinical trials, demonstrating its effectiveness in detecting false-negative smears and improving the overall quality control in cervical cytology screening. ([pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/PMC2678829/?utm_source=openai))

Api Available

no

Certifications

• FDA 510(k) approval
• FDA Premarket Approval (PMA) P950009
• FDA Premarket Approval Supplement S020
• FDA Premarket Approval Supplement S001
• FDA Premarket Approval Supplement S002
• FDA Premarket Approval Supplement S025
• FDA Premarket Approval Supplement S024
• FDA Premarket Approval Supplement S023
• FDA Premarket Approval Supplement S022
• FDA Premarket Approval Supplement S021

Company Founding

1897

Company Offices

• United States
• Germany
• France
• United Kingdom
• India
• China
• Japan
• Brazil
• Mexico
• South Africa

Compliance

• FDA 510(k) approval
• FDA Premarket Approval (PMA) P950009
• FDA Premarket Approval Supplement S020
• FDA Premarket Approval Supplement S001
• FDA Premarket Approval Supplement S002
• FDA Premarket Approval Supplement S025
• FDA Premarket Approval Supplement S024
• FDA Premarket Approval Supplement S023
• FDA Premarket Approval Supplement S022
• FDA Premarket Approval Supplement S021

Customers

Data Residency

FDA-approved device, Clinical trial validated performance, Clinical trial publications available, Clinical trial results published, Clinical trial findings available, Clinical trial outcomes published, Clinical trial evidence available, Clinical trial data available, Clinical trial support, Clinical evaluation studies

Data Standards

• FDA 510(k) approval
• FDA Premarket Approval (PMA) P950009
• FDA Premarket Approval Supplement S020
• FDA Premarket Approval Supplement S001
• FDA Premarket Approval Supplement S002
• FDA Premarket Approval Supplement S025
• FDA Premarket Approval Supplement S024
• FDA Premarket Approval Supplement S023
• FDA Premarket Approval Supplement S022
• FDA Premarket Approval Supplement S021

Deployment Model

• on_prem

Features

• Automated cervical cytology slide screening
• Quality control rescreening
• Detection of high-grade squamous intraepithelial lesions (HSIL)
• Detection of invasive cervical cancer
• Identification of atypical glandular cells of undetermined significance (AGUS)
• Enhanced detection of false-negative Pap smears
• Improved sensitivity compared to random selection methods
• FDA-approved for primary screening of conventional Pap smear slides
• FDA-approved for use with BD SurePath Pap tests
• Optimized staining and presentation procedures for slide analysis
• Clinical trial validated performance
• Multicenter clinical trial support
• Prospective and archival sensitivity studies
• Clinical evaluation studies
• Clinical trial data available
• Clinical trial publications available
• Clinical trial results published
• Clinical trial findings available
• Clinical trial outcomes published
• Clinical trial evidence available

Id

SW0651

Integration Partners

Integrations

• BD SurePath Pap tests
• BD FocalPoint Slide Profiler

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise

Optional Modules

• BD SurePath Pap test compatibility
• BD FocalPoint Slide Profiler integration
• BD SurePath slide analysis
• BD SurePath slide screening
• BD SurePath slide rescreening
• BD SurePath slide detection
• BD SurePath slide identification
• BD SurePath slide validation
• BD SurePath slide optimization
• BD SurePath slide performance

Os Platforms

• Windows

Pricing Details

Contact BD Diagnostics for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• FDA-approved device
• Clinical trial validated performance
• Clinical trial publications available
• Clinical trial results published
• Clinical trial findings available
• Clinical trial outcomes published
• Clinical trial evidence available
• Clinical trial data available
• Clinical trial support
• Clinical evaluation studies

Product Code

SW0651

Product Name

AUTOPAP 300 QC SYSTEM

Ratings

Regions Available

• United States
• Europe
• Asia
• Australia
• Canada
• Latin America
• Africa

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• FDA-approved device
• Clinical trial validated performance
• Clinical trial publications available
• Clinical trial results published
• Clinical trial findings available
• Clinical trial outcomes published
• Clinical trial evidence available
• Clinical trial data available
• Clinical trial support
• Clinical evaluation studies

Specialties

• Cervical Cytology
• Pathology
• Oncology
• Gynecology

Support Channels

System Requirements

Windows OS, BD SurePath Pap tests, BD FocalPoint Slide Profiler

Target Users

• cytology laboratory personnel
• cytology supervisors
• laboratory managers
• pathologists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

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    "FDA Premarket Approval Supplement S002",
    "FDA Premarket Approval Supplement S025",
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    "FDA Premarket Approval Supplement S002",
    "FDA Premarket Approval Supplement S025",
    "FDA Premarket Approval Supplement S024",
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    "FDA Premarket Approval Supplement S002",
    "FDA Premarket Approval Supplement S025",
    "FDA Premarket Approval Supplement S024",
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