{"entity":{"id":"bd-surepath","kind":"drug","name":"BD SurePath liquid-based Pap test and PrepStain slide processor","aka":["SurePath","PrepStain","AutoCyte PREP"],"tldr":"BD's liquid-based Pap test, approved in 1999 as AutoCyte PREP and renamed SurePath in 2001.","summary":"The FDA approved the AutoCyte PREP system on 17 June 1999 (PMA P970018) as a liquid-based, thin-layer cell preparation producing slides \"intended as replacements for conventional gynecologic Pap smears\". On 2 November 2001 (S003) the names changed to PrepStain System and SurePath. The FDA applicant is BD Diagnostic Systems, and the BD Onclarity HPV approval held by Becton, Dickinson and Company names the BD SurePath vial. SurePath vials are a specimen type in the FDA approvals of the BD Onclarity and Alinity m HPV tests.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P970018","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970018"}],"tags":["test","screening-test"],"related":["thinprep","bd-onclarity-hpv","automated-pap-screening-readers","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":["becton-dickinson"],"institutions":[],"pathways":[],"terms":["cin-hsil","screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"BD SurePath","modality":"Liquid-based cervical cytology (Pap test) slide processor","mechanism":"Cervical cells are collected into a preservative fluid; the processor prepares a thin layer of cells on a slide to replace the conventional smear.","approvals":[{"region":"US","year":1999,"indication":"Liquid-based thin-layer cervical cytology preparation (PMA P970018)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/bd-surepath/","neighbours":{"drug":[{"id":"automated-pap-screening-readers","kind":"drug","name":"Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System","route":"/drugs/automated-pap-screening-readers/"},{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","route":"/drugs/bd-onclarity-hpv/"},{"id":"thinprep","kind":"drug","name":"ThinPrep Pap Test and ThinPrep processors (Hologic)","route":"/drugs/thinprep/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"hpv-testing","kind":"technology","name":"HPV DNA testing and self-sampling","route":"/technologies/hpv-testing/"}],"company":[{"id":"becton-dickinson","kind":"company","name":"BD (Becton, Dickinson and Company)","route":"/companies/becton-dickinson/"}],"term":[{"id":"cin-hsil","kind":"term","name":"Cervical precancer (CIN, HSIL/LSIL)","route":"/terms/cin-hsil/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}