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Aptima HCV Quant Dx Assay

by Hologic, Inc.

PMA P160023510(k) K233352

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233352 Date24 Jul 2024ClearedStatusActive
United StatesFDA PMA PMA NumberP160023 Date13 Feb 2017ApprovedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233352 decided 24 Jul 2024 Active
  • FDA PMA P160023 decided 13 Feb 2017 Active

Timeline

2 dated events

  1. Approved FDA PMA P160023
  2. Cleared FDA 510(k) K233352

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Generic name
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
PMA number
510(k) Number
FDA product code
MZP
Device class
Class II
Regulation
21 CFR Part 866.3170
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

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 HCV Quant Dx Assay is a real-time transcription-mediated amplification (TMA) test classified as an assay for hybridization and/or nucleic acid amplification. It is designed for the detection and quantitation of hepatitis C virus (HCV) RNA in human serum and plasma, including specimens collected in EDTA, ACD solution, or plasma preparation tubes, as well as serum from separator or standard tubes. The assay validates detection and quantitation for HCV genotypes 1 through 6 and is intended for use in clinical microbiology settings to aid in diagnosing active HCV infection and monitoring treatment response in infected patients.

The assay is supplied as a reagent kit for use with the Panther system, which automates specimen processing, amplification, detection, and quantitation. It is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. The device is authorized under FDA 510(k) and PMA pathways, with no specific MRI safety or sterility requirements stated beyond standard laboratory handling. Specimens must be stored and transported according to clinical laboratory protocols for nucleic acid testing, adhering to applicable regulatory guidelines for infectious disease diagnostics.

Devices cleared under K233352

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

This record carries 2 submission numbers: K233352, P160023. The table lists K233352.

Devices cleared under K233352
UDI-DISize and differences
Aptima® KIT, CALIBRATOR, HCV QUANT, US IVD
Hologic
PRD-03707 / KIT, CALIBRATOR, HCV QUANT, US IVD15420045506800 —On the market
Aptima® KIT, CONTROLS, HCV QUANT, US IVD
Hologic
PRD-03706 / KIT, CONTROLS, HCV QUANT, US IVD15420045506794 —On the market
Aptima® KIT, MAIN ASSAY, HCV QUANT, 100T, US IVD
Hologic
ASY-08775 / KIT, MAIN ASSAY, HCV QUANT, 100T, US IVD15420045506787 —On the market

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