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Aptima HPV Assay

by Gen-Probe Incorporated

PMA P100042

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P100042↗

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 NumberP100042 Date28 Oct 2011ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1586-2026 FDA Class II initiated 18 Feb 2026

    Due to product exhibiting potential to generate either invalid or false negative results.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Kit, rna detection, human papillomavirus
PMA Number
FDA Product Code
OYB
Device Class
Class III
Advisory Committee
Microbiology
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 Aptima HPV Assay is an in vitro nucleic acid amplification test designed for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. It identifies HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without distinguishing between them. This assay is intended for use with ThinPrep Pap test vials containing PreservCyt solution and specimens collected via broom-type devices or cytobrush/spatula collection tools.

The assay operates on the TIGRIS DTS system and is authorized for clinical use in the United States under an FDA PMA approval (P100042). It is supplied as a kit and is intended for laboratory use to screen patients aged 21 and older with atypical squamous cells of undetermined significance (ASC-US) cytology results or to adjunctively screen women aged 30 and older alongside cervical cytology. The test results are not intended to replace colposcopy referrals but may aid in patient management decisions based on clinical assessment and guidelines.

Other devices from Gen-Probe Incorporated

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 patient populations is the APTima HPV Assay authorized for use in, and how does it integrate with existing screening protocols?

    The APTima HPV Assay is authorized for use in patients aged 21 and older with atypical squamous cells of undetermined significance (ASC-US) cytology results to help determine if colposcopy referral is needed. For women aged 30 and older, it can be used adjunctively alongside cervical cytology to screen for the presence of 14 high-risk HPV types. The test results are not meant to replace clinical judgment or colposcopy referrals but may assist in patient management decisions when combined with physician assessment, cytology history, risk factors, and professional guidelines.

  • What types of cervical specimens are compatible with the APTima HPV Assay, and what collection methods are recommended?

    The APTima HPV Assay is designed to work with cervical specimens collected in ThinPrep Pap test vials containing PreservCyt solution. Specimens must be obtained using either broom-type devices (such as the Wallach Pipette) or endocervical brush/spatula collection tools. Only these specific collection methods and specimen types are authorized for use with the assay.

  • How is the APTima HPV Assay supplied, and what system is required for testing?

    The APTima HPV Assay is supplied as a kit and is intended for laboratory use only. Testing requires the TIGRIS DTS system, which is specifically designed to process and analyze the assay results. The kit and system work together to detect E6/E7 viral mRNA from the 14 high-risk HPV types in cervical specimens.

  • Does the APTima HPV Assay distinguish between the different high-risk HPV types it detects?

    No, the APTima HPV Assay does not differentiate between the 14 high-risk HPV types it detects (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). It provides a qualitative result indicating the presence or absence of any of these types collectively, without specifying which type is present.

  • What regulatory pathway was followed for the approval of the APTima HPV Assay, and where is it authorized for clinical use?

    The APTima HPV Assay was authorized for clinical use in the United States through an FDA Premarket Approval (PMA) process, with the approval granted under PMA number P100042. This approval specifically authorizes its use in the U.S. market as described in the indications for use, including screening and adjunctive screening protocols.