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510(k) K251993

Panther Fusion GI Expanded Bacterial Assay by Hologic, Inc. — Product Code PCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Device Class
Class II
Regulation Number
866.3990
Review Panel
MI
Submission Type

A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.

Other clearances by Hologic, Inc.

  • K251868 — Panther Fusion GI Bacterial Assay (September 25, 2025)
  • 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)
  • K233352 — Aptima HCV Quant Dx Assay (July 24, 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 PCH

  • K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx (March 9, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx (October 22, 2025)
  • K251868 — Panther Fusion GI Bacterial Assay (September 25, 2025)
  • K250324 — QIAstat-Dx GI Panel 2 Mini B (February 28, 2025)
  • K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (January 16, 2025)
  • K242877 — BioCode Gastrointestinal Pathogen Panel (GPP) (January 10, 2025)
  • K243813 — QIAstat-Dx GI Panel 2 Mini B&V (January 8, 2025)
  • K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (November 7, 2024)
  • K220062 — QIAstat-Dx Gastrointestinal Panel 2 (May 31, 2024)