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510(k) K233352

Aptima HCV Quant Dx Assay by Hologic, Inc. — Product Code MZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Device Class
Class II
Regulation Number
866.3170
Review Panel
MI
Submission Type

Other clearances by Hologic, Inc.

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  • K243341 — Genius AI Detection 2.0 (July 31, 2025)
  • K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
  • K243935 — Aptima CMV Quant Assay (January 17, 2025)
  • K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
  • K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (November 15, 2024)
  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
  • K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (July 18, 2024)
  • DEN210035 — “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (January 31, 2024)

Other clearances for product code MZP

  • K252484 — cobas HCV (November 3, 2025)
  • K252102 — Alinity m HCV (September 25, 2025)
  • K221007 — cobas HCV (November 4, 2022)