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BD's liquid-based Pap test, approved in 1999 as AutoCyte PREP and renamed SurePath in 2001.
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.
Cervical cells are collected into a preservative fluid; the processor prepares a thin layer of cells on a slide to replace the conventional smear.
| Region | Year | Indication |
|---|---|---|
| US | 1999 | Liquid-based thin-layer cervical cytology preparation (PMA P970018) |
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Query for this drug: (TITLE:"BD SurePath liquid-based Pap test and PrepStain slide processor" OR ABSTRACT:"BD SurePath liquid-based Pap test and PrepStain slide processor" OR TITLE:"BD SurePath" OR ABSTRACT:"BD SurePath" OR TITLE:"SurePath" OR ABSTRACT:"SurePath" OR TITLE:"PrepStain" OR ABSTRACT:"PrepStain" OR TITLE:"AutoCyte PREP" OR ABSTRACT:"AutoCyte PREP") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about BD SurePath liquid-based Pap test and PrepStain slide processor, not a curated reading list.
Shares Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System, ThinPrep Pap Test and ThinPrep processors (Hologic), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares BD Onclarity HPV Assay (extended genotyping), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares ThinPrep Pap Test and ThinPrep processors (Hologic), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares ThinPrep Pap Test and ThinPrep processors (Hologic), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares BD Onclarity HPV Assay (extended genotyping), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares BD Onclarity HPV Assay (extended genotyping), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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