Definition: 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 Dete
| Device Type ID | 3555 |
| Device Name | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Physical State | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay Systems Are Devices That Consist Of Reagents And Instruments For The Simultaneous Detection And Identification Of Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Huma |
| Technical Method | A Qualitative In Vitro Diagnostic Assay 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 N |
| Target Area | In Vitro Diagnostic Device |
| Regulation Description | Gastrointestinal Microorganism Multiplex Nucleic Acid-based Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3990 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3555 |
| Device | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Product Code | PCH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Microorganism Multiplex Nucleic Acid-based Assay. |
| CFR Regulation Number | 866.3990 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED BIOCODE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BIOFIRE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CEPHEID | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GREAT BASIN SCIENTIFIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
LUMINEX MOLECULAR DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
NANOSPERE,INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOSPHERE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Luminex Corporation | II | Oct-11-2018 |
| 2 | Nanosphere, Inc. | II | Sep-23-2014 |