Chrysalis Intelligence · Product Codes · PCH

PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Microbiology · 16 clearances · 8 unique sponsors

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Device class

Class II

Regulation 866.3990

Total clearances

2022-08-19 → 2026-05-19

Last 12 months

Unique sponsors

Definition

What is Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

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.

Classification details

Medical specialty

Microbiology

Review panel

Regulation number

866.3990

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
QIAGEN GmbH	5	2	2026-03-09
Biofire Diagnostics, LLC	3	0	2025-01-16
Becton, Dickinson and Company	2	0	2022-09-21
Hologic	2	2	2025-09-25
Cepheid	1	1	2026-01-16
Applied BioCode, Inc.	1	0	2025-01-10
Genetic Signatures Limited	1	0	2024-05-29
Luminex Corporation	1	1	2026-05-19

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
87507	CPT	—	High	Gastrointestinal pathogen panel, nucleic acid-based multiplex assay
87801	CPT	—	Medium	Infectious agent detection by nucleic acid; multiplex respiratory panel analogue

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-19	K253722	Luminex Corporation	LIAISON PLEX Gastrointestinal Flex Assay
2026-03-09	K254032	QIAGEN GmbH	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
2026-01-16	K251721	Cepheid	Xpert GI Panel
2025-10-22	K252329	QIAGEN GmbH	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
2025-09-25	K251993	Hologic, Inc.	Panther Fusion GI Expanded Bacterial Assay
2025-09-25	K251868	Hologic	Panther Fusion GI Bacterial Assay
2025-02-28	K250324	QIAGEN GmbH	QIAstat-Dx GI Panel 2 Mini B
2025-01-16	K243885	Biofire Diagnostics, LLC	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
2025-01-10	K242877	Applied BioCode, Inc.	BioCode Gastrointestinal Pathogen Panel (GPP)
2025-01-08	K243813	QIAGEN GmbH	QIAstat-Dx GI Panel 2 Mini B&V
2024-11-07	K242367	Biofire Diagnostics, LLC	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
2024-05-31	K220062	QIAGEN GmbH	QIAstat-Dx Gastrointestinal Panel 2
2024-05-29	K232672	Genetic Signatures Limited	EasyScreen Gastrointestinal Parasite Detection Kit
2023-03-16	K230404	Biofire Diagnostics, LLC	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
2022-09-21	K220607	Becton, Dickinson and Company	BD MAX Enteric Viral Panel
2022-08-19	K220193	Becton, Dickinson and Company	BD MAX Enteric Parasite Panel