Monoprep Pap Test

FDA premarket approval P040052 · Processor, cervical cytology slide, automated

PMA numberP040052

Approval

Applicant
Hologic, Inc.
Received
December 30, 2004
Decision date
March 3, 2006 (APWD)
Supplements
7, latest October 16, 2008
Product code
MKQ – Processor, Cervical Cytology Slide, Automated

Official FDA PMA record

Approval order statement

APPROVAL FOR THE MONOPREP PAP TEST (MPPT). THE DEVICE IS INTENDED FOR USE IN COLLECTING AND PREPARING CERVICAL-VAGINAL CYTOLOGY SPECIMENS FOR PAP STAIN-BASED SCREENING FOR CERVICAL CANCER, IT'S PRECURSOR LESIONS, AND OTHER CYTOLOGICAL CATEGORIES AND CONDITIONS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY. THE MONOPREP PAP TEST PRODUCES SLIDES THAT ARE INTENDED TO REPLACE CONVENTIONALLY PREPARED PAP SMEAR SLIDES.