# Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System

Source: https://onco.cc/drugs/automated-pap-screening-readers/  
OnCo record `automated-pap-screening-readers` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Machines that scan Pap slides and point the human reader to the cells most likely to be abnormal, approved in the United States from 1995 onwards.

## Summary

Three automated readers hold FDA approvals under the product code for automated cervical cytology slide readers. The AutoPap 300 QC system (PMA P950009, 29 September 1995) was renamed the FocalPoint System in 2001 (applicant BD Diagnostics, of Becton, Dickinson and Company), and the BD FocalPoint GS Imaging System, approved on 3 December 2008, assists cervical screening of SurePath slides and ranks them by the likelihood of abnormality. The ThinPrep Imaging System (Hologic, PMA P020002, 6 June 2003) is indicated for assisting in primary cervical cancer screening of ThinPrep Pap slides for atypical cells, cervical neoplasia and its precursor lesions. The first, the Papnet Testing System (PMA P940029, approved 8 November 1995), is recorded by the FDA as withdrawn. The digital successor with an artificial intelligence algorithm is a separate record.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: BD FocalPoint; FocalPoint GS Imaging System; ThinPrep Imaging System; Papnet
- Tags: test; screening-test
- Modality: Automated Pap test slide reader (computer-assisted cervical cytology screening)
- Mechanism: An imaging system scans Pap slides and ranks them, or directs the cytologist to the fields most likely to hold abnormal cells.
- Approvals: US 1995: AutoPap 300 QC, later FocalPoint (PMA P950009); US 2003: ThinPrep Imaging System, assisting in primary cervical cancer screening of ThinPrep Pap slides (PMA P020002)

## Sources

- FDA PMA P950009: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950009
- FDA PMA P020002: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020002
- FDA PMA P940029: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P940029

## Connected records

- drugs: [BD SurePath liquid-based Pap test and PrepStain slide processor](https://onco.cc/drugs/bd-surepath/), [Genius Digital Diagnostics System with Genius Cervical AI (Hologic)](https://onco.cc/drugs/genius-digital-diagnostics/), [ThinPrep Pap Test and ThinPrep processors (Hologic)](https://onco.cc/drugs/thinprep/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [HPV DNA testing and self-sampling](https://onco.cc/technologies/hpv-testing/)
- companies: [BD (Becton, Dickinson and Company)](https://onco.cc/companies/becton-dickinson/), [Hologic](https://onco.cc/companies/hologic/)
- terms: [Cervical precancer (CIN, HSIL/LSIL)](https://onco.cc/terms/cin-hsil/), [Screening](https://onco.cc/terms/screening/)

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