MONOPREP PAP TEST

FDA premarket approval P040052 · decided 2006-03-03

Approval details

PMA number

P040052

Trade name

MONOPREP PAP TEST

Generic name

Processor, cervical cytology slide, automated

Applicant

Hologic, Inc.

Date received

2004-12-30

Decision date

2006-03-03

Days to decision

428 days

Decision code

APWD

Product code

MKQ

Advisory committee

Pathology

Expedited review

No

Location

Malborough, MA

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.

510(k) clearances by this applicant