(109 days)
The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplexed in vitro diagnostic test intended for use with the BioCode MDx 3000 Instrument. The BioCode GPP is capable of the simultaneous detection of nucleic acids from multiple bacteria, viruses, and parasites extracted directly from unpreserved in Cary-Blair transport medium obtained from individuals with simptoms of gastrointestinal infection. The following bacteria, parasites, and viruses are identified using the BioCode Gastrointestinal Pathogen Panel:
- . Campylobacter (C. jejuni/C. coli)
- Clostridium difficile (C. difficile) toxin A/B (Fresh samples only)
- l Salmonella spp
- Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio parahaemolyticus .
- . Yersinia enterocolitica
- . Enteroaggregative Escherichia coli (EAEC)
- Enterotoxigenic Escherichia coli (ETEC) lt/st
- E. coli 0157 serogroup
- Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2
- Shigella/ Enteroinvasive Escherichia coli (EIEC)
- Cryptosporidium spp (C. parvum/C. hominis)
- Entamoeba histolytica
- Giardia lamblia (also known as G. intestinalis and G. duodenalis)
- . Adenovirus F 40/41
- Norovirus GI/GII ■
- . Rotavirus A
The BioCode GPP is indicated as an aid in the diagnosis of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. For In Vitro Diagnostic Use Only. For Prescription Use Only.
Positive results do not rule out co-infection with organisms not included in the BioCode GPP. The agent detected may not be the definite cause of the disease. Negative results in the setting of clinical illness compatible with gastroenteriis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection.
Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Adenovinus 40/41, Campylobacter, E. coli 0157, Shigella(EIEC, Yersinia enterocolitica, and Giardia lamblia were established additionally with retrospective clinical specimens. Performance characteristica, Giardia lamblia, Yersinia enterocolitica and Vibrio (V. parahaemolyticus, V. cholerae) were established primarily using contrived clinical specimens.
The BioCode® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid-based test designed to be used with the BioCode MDx-3000 system. The BioCode MDx-3000 is an automated system that integrates PCR amplification, target capture, signal generation and optical detection for multiple gastrointestinal pathogens from a single stool specimen, either unpreserved or in Cary Blair. Stool specimens are processed, and nucleic acids extracted with easyMAG, MagNA Pure 96, KingFisher Flex and KingFisher Apex Dx. Once the PCR plate is set up and sealed, all other operations are automated on MDx-3000. The BioCode MDx-3000 Gastrointestinal Infection Panel simultaneously tests for 17 pathogens (see table below) from unpreserved stool specimens or stool collected in Cary-Blair transport medium. Results from the BioCode Gastrointestinal Pathogen Panel (GPP) test are available within less than 4 hours.
The provided text describes the BioCode Gastrointestinal Pathogen Panel (GPP), a diagnostic test for gastrointestinal pathogens, and a study to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each pathogen are implied by the reported Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to the easyMAG extraction method (used with the predicate device) for each extraction system (KingFisher Flex and KingFisher Apex Dx). While explicit pre-defined acceptance criteria values are not stated, the tables present the achieved performance with 95% Confidence Intervals. Generally, a high PPA and NPA (typically >90-95%) with narrow confidence intervals are expected for substantial equivalence for diagnostic tests.
Here's a summary of the reported performance for the BioCode GPP using KingFisher Flex and KingFisher Apex Dx, focusing on the "All Archived" data as it covers a larger sample size for each target. Targets with PPA
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).