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AutoPap 300 QC Automatic Pap Screener/QC System

by Bd Diagnostics

PMA P950009

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P950009↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP950009 Date29 Sep 1995ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0081-2019 FDA Class III initiated 21 Sep 2018

    The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual screening. Therefore, no slides are screened by the device and no results can be released in error. The instrument labeling has been revised to indicate an operating temperature lower limit of 18 deg. C and operating humidity of 20 to 80% relative humidity.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Autopap(R) 300 Qc Automatic Pap Screener/Qc System
Generic Name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
PMA Number
FDA Product Code
MNM
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AutoPap 300 QC is an automated cervical cytology slide reader system designed for laboratory use. It functions as an automated screening tool to assist in the quality control process of cervical cytology slides.

This system is manufactured by BD Diagnostics and has received FDA PMA authorization. It is intended for use in clinical pathology settings to support standardized slide evaluation procedures.

Other devices from Bd Diagnostics

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the AutoPap 300 QC?

    The AutoPap 300 QC functions as an automated reader for cervical cytology slides, designed to assist in the quality control and screening processes within a laboratory environment.

  • Who is the manufacturer of this system?

    The AutoPap 300 QC is manufactured by BD Diagnostics, based in Durham, North Carolina.

  • Is the AutoPap 300 QC FDA authorized?

    Yes, the system has received FDA PMA authorization, which confirms it has undergone the premarket approval process required for this class of medical device.