Panther Fusion GI Bacterial Assay
FDA 510(k) K251868 · Hologic
Submission
- Device name
- Panther Fusion GI Bacterial Assay
- Applicant
- Hologic
San Diego, CA, US - Received
- June 18, 2025
- Decision date
- September 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Specialty
- Microbiology
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…
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|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | Luminex Corporation | 05/19/2026SE |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 03/09/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | Cepheid | 01/16/2026SE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 10/22/2025SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | Hologic, Inc. | 09/25/2025SE |
| K250324 | QIAstat-Dx GI Panel 2 Mini BPCH · Special | QIAGEN GmbH | 02/28/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | Biofire Diagnostics, LLC | 01/16/2025SE |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 01/10/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | QIAGEN GmbH | 01/08/2025SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | Biofire Diagnostics, LLC | 11/07/2024SE |
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| 510(k) | Device | Decision |
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| K254090 | I-View®MUE · Traditional | 09/02/2026SE |
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| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | 06/17/2026SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K243341 | Genius AI Detection 2.0QDQ · Traditional | 07/31/2025SE |
| K243396 | Aptima SARS-CoV-2 AssayQQX · Traditional | 02/13/2025SE |
| K243935 | Aptima CMV Quant AssayPAB · Special | 01/17/2025SE |
| K243345 | Aptima BV Assay; Aptima CV/TV AssayPQA · Special | 11/25/2024SE |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF · Traditional | 11/15/2024SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | 07/25/2024SE |
Questions and answers
When was Panther Fusion GI Bacterial Assay cleared by the FDA?
Panther Fusion GI Bacterial Assay (K251868) received a 510(k) decision of Substantially Equivalent on September 25, 2025, 99 days after the submission was received.
What is the product code of K251868?
The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.