Progastro SSCS Assay
FDA 510(k) K123274 · Gen-Probe Prodesse, Inc.
Submission
- Device name
- Progastro SSCS Assay
- Applicant
- Gen-Probe Prodesse, Inc.
Waukesha, WI, US - Received
- October 19, 2012
- Decision date
- January 16, 2013
- 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…
Other 510(k)s with product code PCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | Hologic | 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 |
More from QIAGEN GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K132238 | Proparaflu+ AssayOOU · Special | 08/26/2013SE |
| K132237 | Prodesse Profast+ AssayOQW · Special | 08/26/2013SE |
| K132200 | Pro Hmpv+ AssayOEM · Special | 08/14/2013SE |
| K132159 | Proadeno+ AssayOCC · Special | 08/14/2013SE |
| K132129 | Prodesse Proflu+ AssayOCC · Special | 08/09/2013SE |
| K123838 | Pro Hmpv+ AssayOEM · Special | 01/16/2013SE |
| K110968 | Proflu+ AssayOCC · Traditional | 06/27/2011SE |
| K102952 | Prodesse ProadenoOCC · Traditional | 12/03/2010SE |
| K101855 | Profast+ AssayOQW · Traditional | 07/23/2010SE |
Questions and answers
When was Progastro SSCS Assay cleared by the FDA?
Progastro SSCS Assay (K123274) received a 510(k) decision of Substantially Equivalent on January 16, 2013, 89 days after the submission was received.
What is the product code of K123274?
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.