BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System

K250358 · Becton, Dickinson and Company · PCI · Oct 31, 2025 · Microbiology

Device Facts

Record IDK250358
Device NameBD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
ApplicantBecton, Dickinson and Company
Product CodePCI · Microbiology
Decision DateOct 31, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 866.3990
Device ClassClass 2
AttributesPediatric

Indications for Use

BD Enteric Bacterial Panel for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR™ System detects nucleic acids from: - Salmonella spp. - Campylobacter spp. (C. jejuni and C. coli) - Shigella spp. / Enteroinvasive Escherichia coli (EIEC) - Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, and Shiga toxin-producing E. coli (STEC). Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. BD Enteric Bacterial Panel plus for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel plus for BD COR™ System detects nucleic acids from: - Salmonella spp. - Campylobacter spp. (C. jejuni and C. coli) - Shigella spp. / Enteroinvasive Escherichia coli (EIEC) - Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. - Plesiomonas shigelloides - Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae) - Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT) / heat-stable enterotoxin (ST) genes - Yersinia enterocolitica Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, Shiga toxin-producing E. coli (STEC), Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic Escherichia coli (ETEC) LT/ST, and Yersinia enterocolitica. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. The Enteric Bacterial Panel Diluent for BD COR™ System is intended to be used in clinical settings according to instructions provided for aliquoting into Molecular Aliquot Tubes by the BD COR™ System. The Enteric Bacterial Panel Diluent for BD COR™ System is only for use with BD Fecal Collection and Transport Kit specimens tested on BD COR™ Systems.

Device Story

Automated in vitro diagnostic system; utilizes BD Fecal Collection and Transport Kit for stool specimen collection. System performs pre-analytical steps (vortexing, aliquoting, pre-warming/cooling) via BD COR PX; transfers samples to BD COR MX Analyzer for nucleic acid extraction, purification, and real-time PCR amplification. Uses magnetic affinity beads for extraction; hydrolysis (TaqMan) probes for detection. Provides qualitative results (positive/negative) for enteric bacterial pathogens. Used in clinical laboratories; operated by laboratory personnel. Results aid differential diagnosis in conjunction with clinical/epidemiological data; not for sole diagnostic use.

Clinical Evidence

Multi-site prospective and retrospective clinical study (n=1,807 compliant specimens). Performance evaluated against FDA-cleared PCR assays or composite comparator methods. PPA/NPA metrics reported for all targets. Salmonella PPA 94.7-98.3%; Campylobacter PPA 100%; Shigella/EIEC PPA 80.0-94.4%; Shiga toxin PPA 100%; Plesiomonas PPA 66.7-100%; Vibrio PPA 100%; ETEC PPA 42.9-100%; Yersinia PPA 100%. Contrived specimen testing supplemented low-prevalence targets.

Technological Characteristics

Automated real-time PCR assay. Uses magnetic affinity beads for nucleic acid extraction. Detection via hydrolysis (TaqMan) probes with fluorophores. Reagents provided in dried 96-well microtiter plates. System: BD COR (PX System + MX Analyzer). Connectivity: LIS integration. Sterilization: Not specified. Software: Automated instrument control and data interpretation.

Indications for Use

Indicated for symptomatic patients (pediatric/adult) with suspected acute gastroenteritis, enteritis, or colitis. Used for qualitative detection/differentiation of enteric bacterial pathogens from unpreserved soft to diarrheal stool specimens.

Regulatory Classification

Identification

A gastrointestinal microorganism multiplex nucleic acid-based 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 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.

Special Controls

*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).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT ## I Background Information: A 510(k) Number K250358 B Applicant Becton, Dickinson and Company C Proprietary and Established Names BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | PCI | Class II | 21 CFR 866.3990 - Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay | MI - Microbiology | ## II Submission/Device Overview: A Purpose for Submission: To obtain a substantial equivalence determination for the BD Enteric Bacterial Panel for BD COR System and the BD Enteric Bacterial Panel plus for BD COR System. B Measurand: The BD Enteric Bacterial Panel for BD COR System detects target DNA sequences for: - Campylobacter spp. (C. jejuni and C. coli) - Salmonella spp. - Shigella spp. / Enteroinvasive E. coli (EIEC) Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} - Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. The BD Extended Enteric Bacterial Panel plus for BD COR System detects target DNA sequences for: - Campylobacter spp. (C. jejuni and C. coli) - Salmonella spp. - Shigella spp. / Enteroinvasive E. coli (EIEC) - Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. - Enterotoxigenic E. coli (ETEC) heat-labile enterotoxin (LT)/ heat-stable enterotoxin (ST) genes - Plesiomonas shigelloides - Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae) - Yersinia enterocolitica ## C Type of Test: The BD MAX Enteric Bacterial Panel for BD COR System is a qualitative real-time polymerase chain reaction (PCR) assay for the amplification and detection of DNA from Salmonella spp., Shigella spp., and Campylobacter spp., as well as the toxin genes stx1 and stx2 found in Shiga toxin-producing E. coli (STEC). The BD MAX Enteric Bacterial Panel plus for BD COR System is a qualitative real-time polymerase chain reaction (PCR) assay for the amplification and detection of DNA from Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae), and Yersinia enterocolitica, as well as toxin genes health-labile enterotoxin (LT)/and heat-stable enterotoxin (ST) genes from Enterotoxigenic E. coli (ETEC). ## III Intended Use/Indications for Use: ### A Intended Use(s): See Indications for Use below. ### B Indication(s) for Use: BD Enteric Bacterial Panel for BD COR System The BD Enteric Bacterial Panel for BD COR System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR System detects nucleic acids from: - Salmonella spp. - Campylobacter spp. (C. jejuni and C. coli) - Shigella spp. / Enteroinvasive Escherichia coli (EIEC) K250358 - Page 2 of 32 {2} - Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, and Shiga toxin-producing E. coli (STEC). Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. BD Enteric Bacterial Panel plus for BD COR System BD Enteric Bacterial Panel plus for BD COR System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel plus for BD COR System detects nucleic acids from: - Salmonella spp. - Campylobacter spp. (C. jejuni and C. coli) - Shigella spp. / Enteroinvasive Escherichia coli (EIEC) - Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. - Plesiomonas shigelloides - Vibrio spp (V. vulnificus, V. parahaemolyticus, and V. cholerae) - Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT) / heat-stable enterotoxin (ST) genes - Yersinia enterocolitica Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, K250358 - Page 3 of 32 {3} enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, Shiga toxin-producing E. coli (STEC), Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic Escherichia coli (ETEC) LT/ST and Yersinia enterocolitica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. Enteric Bacterial Panel Diluent for BD COR System The Enteric Bacterial Panel Diluent for BD COR System is intended to be used in clinical settings according to instructions provided for aliquoting into Molecular Aliquot Tubes by the BD COR System. The Enteric Bacterial Panel Diluent for BD COR System is only for use with BD Fecal Collection and Transport Kit specimens tested on BD COR Systems. ## C Special Conditions for Use Statement(s): Rx - For Prescription Use Only ## D Special Instrument Requirements: Both assays are performed on the BD COR System. ## IV Device/System Characteristics: ## A Device Description: The BD Enteric Bacterial Panel for BD COR System (BD EBP for BD COR System) simultaneously detects pathogens responsible for gastroenteritis due to Salmonella spp., Campylobacter spp. (C. jejuni and C. coli), Shigella spp./EIEC, stx/stx1/stx2 found in Shiga toxin-producing E. coli and in Shigella dysenteriae, and an internal Sample Processing Control. The BD Enteric Bacterial Panel plus for BD COR Systems (BD EBP plus for BD COR System) additionally detects Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic E. coli (ETEC) LT/ST, Yersinia enterocolitica and an internal Sample Processing Control with a second master mix. The assays automate the testing process and minimize operator intervention from the time the sample is placed onto the BD COR System until results are available. K250358 - Page 4 of 32 {4} The BD COR System is comprised of a single BD COR PX System attached to a BD COR MX Analyzer as described in the published decision summaries for K210585 and K224653. Once the specimens are loaded, the BD COR PX System performs the necessary pre-analytical steps such as vortexing, aliquoting into a diluent filled molecular aliquot tube, sorting/grouping of the secondary samples for testing by assay, pre-warming and cooling of the sample (where required), and transport of the sample into the BD COR MX Analyzer, where extraction, amplification and detection take place. Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates directly with the instrument. Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again prior to result reporting and removal from the system ## B Principle of Operation: The BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System are designed for use with the BD Fecal Collection and Transport Kit for unpreserved soft to diarrheal stool specimens. Specimens are collected and transported to the testing laboratory using the BD Fecal Collection and Transport Kit under conditions of time and temperature that have been determined to maintain the integrity of the target nucleic acids. The BD COR MX Analyzer, when combined with the BD COR PX System, is to be used for automated sample preparation, extraction, and purification of nucleic acids from the BD Fecal Collection and Transport Kit, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR for simultaneous and differential detection of enteric bacteria pathogens. The BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System extraction reagents are dried in 96-well microtiter plates that contain binding magnetic affinity beads and Sample Processing Control (SPC). Each well is capable of binding and eluting sample nucleic acids. The SPC monitors the integrity of the reagents, and the process steps involved in DNA extraction, amplification, and detection, as well as for the presence of potential assay inhibitors. The BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System liquid reagent plate includes Wash, Elution, Neutralization, and Rehydration buffers. The beads together with the bound nucleic acids, are washed and the nucleic acids are eluted by a combination of heat and pH. Eluted DNA is neutralized and transferred to the Amplification reagent to rehydrate the PCR reagents. The BD Enteric Bacterial Panel for BD COR System contains one master mix that contains the dried PCR reagents for the detection and differentiation of Salmonella, Shigella/EIEC, Campylobacter, and Shiga toxin-producing E. coli (STEC), while the BD Enteric Bacterial Panel plus for BD COR System has two distinct master mixes. The first BD Enteric Bacterial Panel plus for BD COR System master contains the same PCR reagents as the BD COR Enteric Bacterial Panel master mix. The second BD Enteric Bacterial Panel plus for BD COR System K250358 - Page 5 of 32 {5} master mix well contains the dried PCR reagents for the detection and differentiation of Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic E. coli (ETEC) LT/ST, and Yersinia enterocolitica. After reconstitution, the BD COR System dispenses a fixed volume of PCR-ready solution containing extracted nucleic acids into the BD PCR cartridge. Microvalves in the BD PCR cartridge are sealed by the system prior to initiating PCR in order to contain the amplification mixture and prevent evaporation and contamination. The amplified DNA targets are detected using hydrolysis (TaqMan) probes, labeled at one end with a fluorescent reporter dye (fluorophore), and at the other end with a quencher moiety. Probes labeled with different fluorophores are used to detect the target analytes in different optical channels of the BD COR System. When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target DNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5'-3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the DNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD COR System monitors these signals at each cycle of the PCR and interprets the data at the end of the reaction to provide qualitative test results for each analyte (i.e., positive or negative). V Substantial Equivalence Information: A Predicate Device Name(s): BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel B Predicate 510(k) Number(s): K214122 C Comparison with Predicate(s): | Device & Predicate Device(s): | K250358 | K214122 | | --- | --- | --- | | Device Trade Name | BD Enteric Bacterial Panel for BD COR System | BD MAX Enteric Bacterial Panel | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | BD Enteric Bacterial Panel for BD COR System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR System detects nucleic acids from: | The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. The BD MAX Enteric Bacterial Panel detects | K250358 - Page 6 of 32 {6} K250358 - Page 7 of 32 | | • Salmonella spp. • Campylobacter spp. (C. jejuni and C. coli) • Shigella spp. / Enteroinvasive Escherichia coli (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. | nucleic acids from: • Salmonella spp. • Campylobacter spp. (jejuni and coli) • Shigella spp. / Enteroinvasive E. coli (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. Testing is performed on unpreserved soft to diarrheal stool specimens or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of SpaO, a Campylobacter specific tuf gene sequence, ipaH and stx1/stx2. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological | | --- | --- | --- | {7} K250358 - Page 8 of 32 | | This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, and Shiga toxin-producing E. coli (STEC). Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. | information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter and Shiga toxin-producing E. coli (STEC) infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. | | --- | --- | --- | | Assay Format | PCR | same | | Targets | • Salmonella spp. • Campylobacter spp. (C. jejuni and C. coli) • Shigella spp. / Enteroinvasive E. coli (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga | same | {8} | | toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC | | | --- | --- | --- | | Assay Controls | Sample processing control | same | | General Device Characteristic Differences | | | | Specimen Type | Stool collected with BD Fecal Collection and Transport Kit (200μL pipetted aliquot) | Unpreserved stool, Cary-Blair preserved stool (10μL transfer loop). FecalSwab Cary-Blair (50μL pipetted aliquot) | | Instrument | BD COR System | BD MAX System | | Sample Buffer | Reformulated | Original | | Specimen Stability | Fecal Collection and Transport Kit only: 2-32°C for 48 hours 2-8°C for 120 hours (5 days) | Unpreserved or Cary-Blair preserved: 2-25°C for 24 hours 2-8°C for 120 hours (5 days) FecalSwab? | | Sample Stability in Sample Buffer Tube: | 2-32°C for 120 hours | 2-25°C for 48 hours 2-8°C for 120 hours (5 days) | | Reagent Stability Extraction tube or Plate, Master Mix Tube or Plate, Reagent Strip or Wet Plate | 2-27°C for 14 months | 2-25°C for 18 months | | Device & Predicate Device(s): | K250358 | K214122 | | --- | --- | --- | | Device Trade Name | BD Enteric Bacterial Panel plus for BD COR System | BD MAX Extended Enteric Bacterial Panel | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | BD Enteric Bacterial Panel plus for BD COR System is an automated in vitro diagnostic test for the direct qualitative detection and | The BD MAX Extended Enteric Bacterial Panel performed on the BD MAX System, is an automated in vitro | K250358 - Page 9 of 32 {9} K250358 - Page 10 of 32 | | differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel plus for BD COR System detects nucleic acids from: • *Salmonella* spp. • *Campylobacter* spp. (*C. jejuni* and *C. coli*) • *Shigella* spp. / Enteroinvasive *Escherichia coli* (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing *Escherichia coli* [STEC]) as well as *Shigella dysenteriae*, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. • *Plesiomonas shigelloides* • *Vibrio* spp. (*V. vulnificus*, *V. parahaemolyticus*, and *V. cholerae*) • Enterotoxigenic *Escherichia coli* (ETEC) heat-labile enterotoxin (LT) / heat-stable enterotoxin (ST) genes • *Yersinia enterocolitica* Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis | diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. It is used in conjunction with the BD MAX Enteric Bacterial Panel as an optional Master Mix. The BD MAX Extended Enteric Bacterial Panel detects nucleic acids from: • *Plesiomonas shigelloides* • *Vibrio* (*V. vulnificus*, *V. parahaemolyticus*, and *V. cholerae*) • Enterotoxigenic *Escherichia coli* (ETEC) heat-labile enterotoxin (LT) / heat-stable enterotoxin (ST) genes • *Yersinia enterocolitica* Testing is performed on unpreserved soft to diarrheal or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of relevant gene target DNA. The test utilizes fluorogenic gene-specific hybridization probes for the detection of the amplified DNA. This test is intended for | | --- | --- | --- | {10} K250358 - Page 11 of 32 | | or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, Shiga toxin-producing E. coli (STEC), Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic Escherichia coli (ETEC) LT/ST and Yersinia enterocolitica. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not | use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae) Enterotoxigenic Escherichia coli (ETEC) LT/ST and Yersinia enterocolitica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. | | --- | --- | --- | {11} K250358 - Page 12 of 32 | | rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis 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. | | | --- | --- | --- | | Assay Format | PCR | same | | Assay Controls | Sample processing control | same | | **General Device Characteristic Differences** | | | | Targets | • *Salmonella* spp. • *Campylobacter* spp. (*C. jejuni* and *C. coli*) • *Shigella* spp. / Enteroinvasive *E. coli* (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing *E. coli* [STEC]) as well as *Shigella dysenteriae*, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC. • *Plesiomonas shigelloides* • *Vibrio* spp. (*V. vulnificus*, *V. parahaemolyticus*, and *V. cholerae*) • Enterotoxigenic *Escherichia coli* | • *Plesiomonas shigelloides* • *Vibrio* spp. (*V. vulnificus*, *V. parahaemolyticus*, and *V. cholerae*) • Enterotoxigenic *Escherichia coli* heat-labile enterotoxin (LT)/heat-stable enterotoxin (ST) genes • *Yersinia enterocolitica* | {12} | | (ETEC) heat-labile enterotoxin (LT)/ heat-stable enterotoxin (ST) genes • Yersinia enterocolitica | | | --- | --- | --- | | Specimen Type | Fecal Collection and Transport Kit Cary-Blair (200μL pipetted aliquot) | Unpreserved stool (10μL transfer loop). FecalSwab Cary-Blair (50μL pipetted aliquot) | | Instrument | BD COR System | BD MAX System | | Sample Buffer | Reformulated | Original | | Specimen Stability | Fecal Collection and Transport Kit only: 2-32°C for 48 hours 2-8°C for 120 hours | Unpreserved or FecalSwab Cary-Blair preserved: 2-25°C for 24 hours 2-8°C for 120 hours | | Sample Stability in SBT | 2-32°C for 120 hours | 2-25°C for 48 hours 2-8°C for 120 hours | | Reagent Stability in Extraction tube or Plate, Master Mix Tube or Plate, Reagent Strip or Wet Plate | 2-27°C for 14 months | 2-25°C for 18 months | VI Standards/Guidance Documents Referenced: 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, November 2, 2015. VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: Since the reagents of the BD Enteric Panel for BD COR System are identical to those contained on the BD Enteric Panel plus for BD COR System, analytical and clinical validation studies utilized only the more expansive BD Enteric Panel plus for BD COR System. Within-laboratory precision was evaluated for the BD Enteric Bacterial Panel plus for BD COR System at one site with one reagent lot. Testing was performed over 12 days, with 2 runs per day per operator, for a total of 48 runs. Test samples were contrived in negative stool matrix and included panel members at distinct target loads for Campylobacter jejuni, Shiga toxin-producing E. coli (stx-1a), Salmonella Typhimurium, Shigella sonnei, K250358 - Page 13 of 32 {13} Plesiomonas shigelloides, Yersinia enterocolitica, Vibrio parahaemolyticus, and Enterotoxigenic E. coli (sta2). Each panel member was tested in triplicate. The following target concentrations were used for spiking levels of the target organisms contained in each panel member: - Moderate Positive (MP): 3x LoD - Low Positive (LP): 2x LoD - True negative (TN): No target Precision study results for the BD Enteric Bacterial Panel plus assay when performed on the BD COR System are described in Table 1. Table 1: BD Enteric Bacterial Panel plus for BD COR System Precision Study Results | Panel | Analyte | Level | Total | Negative | Positive | % Correct | 95% LCL | 95% UCL | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Master Mix 1 | Shigella | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | | MP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | Salmonella | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | | MP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | Campylobacter | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | | MP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | STX | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | | MP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | Master Mix 2 | Vibrio | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | | MP | 72 | 1 | 71 | 98.6% | 92.5% | 99.8% | | | Plesiomonas | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 1 | 71 | 98.6% | 92.5% | 99.8% | | | | MP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | Yersinia | TN | 72 | 72 | 0 | 100.0% | 94.9% | 100.0% | | | | LP | 72 | 0 | 72 | 100.0% | 94.9% | 100.0% | | | | MP | 72 | 1 | 71 | 98.6% | 92.5% | 99.8% | ## Site to Site Reproducibility: The site-to-site reproducibility study was performed at three clinical sites (two external and one internal) using one reagent lot. Two operators performed two runs per day, over five distinct days (consecutive or not), for a total of 60 runs. The panels used were the same as described in the Precision study above. K250358 - Page 14 of 32 {14} The overall site-to-site reproducibility percent agreements were 100% for the TN for all targets and ranged from 98.9% to 100% for both LP and MP panel members. Results are summarized in Table 2. Analysis of variance of the Ct score results from valid tests performed on positive panel members (Table 3) within lab (total) yielded overall CV (%) ranging from 1.0%–3.4% for the MP panel member and 1.3%–3.4% for the LP panel member. Table 2: BD Enteric Bacterial Panel plus for BD COR System Site-to-Site Reproducibility Results | Target | Level | Total | | | --- | --- | --- | --- | | | | Percent Agreement | 95% CI | | Shigella | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 100.0% (90/90) | 95.9%, 100.0% | | | MP | 100.0% (90/90) | 95.9%, 100.0% | | Salmonella | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 100.0% (90/90) | 95.9%, 100.0% | | | MP | 100.0% (90/90) | 95.9%, 100.0% | | Campylobacter | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 100.0% (90/90) | 95.9%, 100.0% | | | MP | 100.0% (90/90) | 95.9%, 100.0% | | STX | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 100.0% (90/90) | 95.9%, 100.0% | | | MP | 100.0% (90/90) | 95.9%, 100.0% | | Vibrio | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 100.0% (90/90) | 95.9%, 100.0% | | | MP | 98.9% (89/90) | 94.0%, 99.8% | | Plesiomonas | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 98.9% (89/90) | 94.0%, 99.8% | | | MP | 100.0% (90/90) | 95.9%, 100.0% | | Yersinia | TN | 100.0% (90/90) | 95.9%, 100.0% | | | LP | 100.0% (90/90) | 95.9%, 100.0% | | | MP | 98.9% (89/90) | 94.0%, 99.8% | Table 3: Variance Component Analysis for Site-to-Site Reproducibility of the BD Enteric Bacterial Panel plus for BD COR System | Target | Level | Total | Mean Ct | Within Run | | Between Run | | Between Day | | Between Site | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Shigella | LP | 90 | 30.4 | 0.37 | 1.2 | 0.31 | 1 | 0.08 | 0.3 | 0.02 | 0.1 | 0.48 | 1.6 | | | MP | 90 | 29.9 | 0.34 | 1.1 | 0.3 | 1 | 0 | 0 | 0 | 0 | 0.45 | 1.5 | | Salmonella | LP | 90 | 31.9 | 0.46 | 1.4 | 0.15 | 0.5 | 0.21 | 0.7 | 0.06 | 0.2 | 0.53 | 1.7 | | | MP | 90 | 31.2 | 0.33 | 1 | 0.21 | 0.7 | 0.14 | 0.4 | 0.13 | 0.4 | 0.43 | 1.4 | | Campylobacter | LP | 90 | 31.9 | 0.39 | 1.2 | 0.18 | 0.6 | 0.03 | 0.1 | 0.14 | 0.4 | 0.45 | 1.4 | | | MP | 90 | 31.3 | 0.29 | 0.9 | 0 | 0 | 0.03 | 0.1 | 0.23 | 0.7 | 0.37 | 1.2 | | STX | LP | 90 | 31.8 | 0.32 | 1 | 0.21 | 0.6 | 0.13 | 0.4 | 0.05 | 0.1 | 0.41 | 1.3 | | | MP | 90 | 31.2 | 0.25 | 0.8 | 0.11 | 0.4 | 0.16 | 0.5 | 0 | 0 | 0.32 | 1 | K250358 - Page 15 of 32 {15} The lot-to-lot reproducibility study was performed over 15 testing days (consecutive days were not required) with 2 operators each testing 1 panel across 2 COR runs (2 COR runs per user, 4 COR runs each day of testing) with 3 replicates per panel at 1 internal site using 3 reagent lots. Total 90 replicates/target. The panels used were the same as described in the Precision study above. The overall lot-to-lot reproducibility percent agreements were $100\%$ for the TN for all targets and ranged from $98.9\%$ to $100\%$ for LP and $97.8\%$ to $100\%$ MP. Results are summarized in Table 4. Table 4: Lot-to-Lot Reproducibility Results for BD Enteric Bacterial Panel plus for BD COR System | Analyte | Level | Percent Agreement Total | | | 95% Confidence Interval | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Shigella | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | MP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | Salmonella | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | MP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | Campylobacter | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | MP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | STX | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | MP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | Vibrio | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 98.9% | 89/90 | ( 94.0% - 99.8% ) | | | | | | MP | 97.8% | 88/90 | ( 92.3% - 99.4% ) | | | | | Plesiomonas | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 98.9% | 89/90 | ( 94.0% - 99.8% ) | | | | | | MP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | Yersinia | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | MP | 98.9% | 89/90 | ( 94.0% - 99.8% ) | | | | | ETEC | TN | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | LP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | | | MP | 100.0% | 90/90 | ( 95.9% - 100.0% ) | | | | K250358 - Page 16 of 32 {16} 2. Linearity: Not applicable 3. Analytical Specificity/Interference: Analytical Reactivity (Inclusivity) A variety of BD Enteric Bacterial Panel plus for BD COR System target strains were included in this study. Strain selection criteria included prevalence, serotype, and geographic location, where appropriate. One-hundred and forty-three (143) strains were tested, including strains from public collections and well-characterized clinical isolates. Inclusivity testing included 26 strains of Salmonella spp., 17 strains of Shigella/EIEC, 18 strains of Campylobacter spp., 26 strains of STEC, 8 strains of Plesiomonas shigelloides, 10 strains of Yersinia enterocolitica, 28 strains of Vibrio (cholerae, parahaemolyticus and vulnificus) and 10 strains of ETEC LT/ST. The strains were tested at ~3x LoD of the corresponding strain in Fecal Collection and Transport Kit. The BD Enteric Bacterial Panel plus for BD COR System correctly identified 143 of the 143 strains tested upon initial testing. Analytical Specificity/Cross-Reactivity The BD Enteric Bacterial Panel plus for BD COR System was performed on samples containing phylogenetically related microorganisms likely to be found in stool specimens. The bacterial cells, yeasts, viruses, and parasites were tested in the Fecal Collection and Transport tube at >1.0 E+06 cells/mL, CFU/mL, genomic DNA cp/mL, or EB/mL, and viruses were tested at 1.0 E+05 viral particles, TCID50/mL or genomic equivalents/mL. Organisms tested are represented in Table 11. - Most of the bacterial strains, yeast, parasites, and viruses tested produced negative results with the BD Enteric Bacterial Panel plus assay. - No cross-reactivity was observed for STEC, Shigella/EIEC, Yersinia enterocolitica, Plesiomonas shigelloides, and ETEC - Campylobacter sputorum biovar sputorum yielded a positive result for Campylobacter spp. during initial testing. However, no positive results were recorded at organism concentrations ≤ 1.0 E+04 CFU/mL in Fecal Collection and Transport Kit. - Adenovirus Type 3 yielded a positive result for Salmonella spp. during initial testing. However, no positive results were recorded at organism concentrations ≤ 7.20 E+04 TCID50/mL. - The following 7 Vibrio species were detected by the BD Enteric Bacterial Panel plus: V. brasiliensis, V. campbellii, V. harveyi, V. hispanicus, V. mimicus, V. nereis, and V. tubiashii. - Two (2) strains of V. mimicus produced positive results with the BD Enteric Bacterial Panel plus assay. However, no positive results were recorded at organism concentrations ≤ 1.0 E+04 cells/mL in Fecal Collection and Transport Kit. K250358 - Page 17 of 32 {17} One (1) strain of V. hispanicus produced positive results with the Enteric Bacterial Panel plus assay. However, no positive results were recorded at organism concentrations $\leq 1.0\mathrm{E} + 03$ cells/mL in Fecal Collection and Transport Kit. One (1) strain of $V.$ campbellii and $V.$ tubiashii produced positive results with the BD Enteric Bacterial Panel plus assay. However, no positive results were recorded at organism concentrations $\leq 1.49\mathrm{E} + 02$ cells/mL in Fecal Collection and Transport Kit. One (1) strain of V. brasiliensis, V. harveyi, and V. nereis produced positive results with the BD Enteric Bacterial Panel plus assay. These strains were still cross-reactant at $1.49\mathrm{E} + 02$ cells/mL in Fecal Collection and Transport Kit. Table 5: Organisms Tested to Determine the BD Enteric Bacterial Panel plus Specificity | Organism | Source | Organism | Source | | --- | --- | --- | --- | | Abiotrophia defectiva | ATCC 49176 | Giardia lamblia | Waterborne P101, H3 Isolate | | Acinetobacter baumannii | ATCC 19606 | Haemophilus influenzae | ATCC 9007 | | Acinetobacter lwoffii | ATCC 15309 | Hafnia alvei | ATCC 13337 | | Adenovirus Type 1 | Zeptometrix 0810050CF | Helicobacter fennelliae | ATCC 35683 | | Adenovirus Type 14 | Zeptometrix 0810108CF | Helicobacter pylori | ATCC 43504 | | Adenovirus Type 3 | Zeptometrix 0810062CF | Herpes Simplex Virus Type 1 | Zeptometrix 0810005CF | | Adenovirus Type 4 | Zeptometrix 0810070CF | Klebsiella oxytoca | ATCC 33496 | | Adenovirus Type 40 | Zeptometrix 0810084CF | Klebsiella pneumoniae subsp. pneumoniae | ATCC 700603 | | Adenovirus Type 41 | Zeptometrix 0810085CF | Lactobacillus acidophilus | ATCC 4356 | | Adenovirus Type 8 | Zeptometrix 0810069CF | Lactobacillus reuteri | ATCC 23272 | | Aeromonas caviae | ATCC 15468 | Lactococcus lactis subsp. lactis | ATCC 11454 | | Aeromonas hydrophila | ATCC 7966 | Listeria monocytogenes | ATCC 15313 | | Aeromonas schubertii | ATCC 43700 | Megasphaera elsdenii | ATCC 25940 | | Aeromonas veronii | ATCC 35623 | Morganella morganii subsp. morganii | ATCC 25830 | | Alcaligenes faecalis subsp. faecalis | ATCC 8750 | Norovirus Group I (recombinant) | Zeptometrix 0810086CF | | Anaerococcus tetradius | ATCC 35098 | Norovirus Group II | ZeptoMetrix 0810087CF | | Arcobacter butzleri | ATCC 49616 | Parabacteroides merdae | ATCC 43184 | | Arcobacter cryaerophilus | ATCC 43158 | Peptoniphilus asaccharolyticus | ATCC 14963 | | Astrovirus Type 4 | Zeptometrix 0810273CF | Peptostreptococcus anaerobius | ATCC 27337 | K250358 - Page 18 of 32 {18} K250358 - Page 19 of 32 | Bacteroides caccae | ATCC 43185 | Porphyromonas asaccharolytica | ATCC 25260 | | --- | --- | --- | --- | | Bacteroides fragilis | ATCC 25285 | Prevotella melaninogenica | ATCC 25845 | | Bacteroides stercoris | ATCC 43183 | Proteus mirabilis | ATCC 25933 | | Bacteroides thetaiomicron | ATCC 29148 | Proteus penneri | ATCC 35198 | | Bacteroides vulgatus | ATCC 8482 | Proteus vulgaris | ATCC 6380 | | Bifidobacterium adolescentis | ATCC 15703 | Providencia alcalifaciens | ATCC 9886 | | Bifidobacterium bifidum | ATCC 29521 | Pseudomonas aeruginosa | ATCC 27853 | | Bifidobacterium longum subsp. longum | ATCC 15707 | Rotavirus | ZeptoMetrix 0810041CF | | Campylobacter hyointestinalis | CCUG 24180 | Ruminococcus bromii | ATCC 27255 | | Campylobacter sputorum biovar sputorum | CCUG 9728 | Serratia fonticola | ATCC 29844 | | Cedecea davisae | ATCC 33431 | Serratia liquefaciens | ATCC 27592 | | Citrobacter freundii | ATCC 8090 | Serratia marcescens subsp. marcescens | ATCC 13880 | | Citrobacter koseri | ATCC 27028 | Shewanella algae | ATCC 51192 | | Citrobacter sedlakii | ATCC 51115 | Shimwellia blattae | ATCC 29907 | | Clostridium difficile | ATCC 43598 | Staphylococcus aureus subsp. aureus | ATCC 43300 | | Clostridium difficile | ATCC 700057 | Staphylococcus epidermidis | ATCC 14990 | | Clostridium histolyticum | ATCC 19401 | Stenotrophomonas maltophilia | ATCC 13637 | | Clostridium novyi | ATCC 19402 | Streptococcus agalactiae | ATCC 13813 | | Clostridium perfringens | ATCC 13124 | Streptococcus intermedius | ATCC 27335 | | Clostridium ramosum | ATCC 25582 | Streptococcus pyogenes | ATCC 19615 | | Clostridium septicum | ATCC 12464 | Streptococcus salivarius subsp. salivarius | ATCC 7073 | | Clostridium sordellii | ATCC 9714 | Streptococcus suis | ATCC 43765 | | Clostridium tetani | ATCC 19406 | Trichomonas vaginalis | ATCC 30001 | | Collinsella aerofaciens | ATCC 25986 | Veillonella parvula | ATCC 10790 | | Cryptosporidium parvum | Waterborne P102M, Iowa isolate | Vibrio alginolyticus | CCUG 16324 | | Cytomegalovirus | Zeptometrix 0810003CF | Vibrio brasiliensis | CCUG 48644 | | Desulfovibrio piger | ATCC 29098 | Vibrio campbellii | CCUG 16330 | | Edwardsiella tarda | ATCC 15947 | Vibrio harveyi | CCUG 23159 | {19} Interfering Substances Twenty-six biological and chemical substances that may occasionally be present in stool specimens were evaluated for potential interference with the BD Enteric Bacterial Panel plus for BD COR System. Eight of these substances were antibiotics tested together as a pool with each antibiotic at a concentration that may be found in a stool sample. Of the 26 substances tested, one demonstrated interference. Anti-Fungal cream was found to interfere at levels above 25%. Results demonstrated no reportable interference with any other substance tested. Table 6 lists all tested substances and the concentrations at which no interference was observed. In addition, microorganisms that may be endogenously present in stool specimens were evaluated for potential interference with the BD Enteric Bacterial Panel plus for BD COR System. Fourteen microorganisms were tested at high concentration (> 2.00E+06 CFU/mL of stool). Table 7 lists all microorganisms tested and the concentrations at which no interference was observed. Table 6: Exogenous and Endogenous Substances Tested for Interference | Substance | Concentration in Stool Where Interference Not Observed | Substance | Concentration in Stool Where Interference Not Observed | | --- | --- | --- | --- | | Fecal Fats | 7.0 mg/mL | Ex-Lax | 14.0 mg/mL | | Human DNA | 21.9 μg/mL | Pepto Bismol | 59.0 mg/mL | | Mucus | 12.5 mg/mL | Amoxicillin trihydrate | 64.0 mg/mL | | Whole Human Blood | 50% | Metronidazole | 60.8 mg/mL | | Hydrocortisone | 15% | Tetracycline HCl | 16.0 mg/mL | | Moist Towelettes | 3 mm2 (in FCT) | Ceftriaxone | 15.8 mg/mL | | Mineral Oil | 50% | Sulfamethoxazole | 80.0 mg/mL | | Preparation H | 50% | Trimethoprim | 16.0 mg/mL | | Nystatin Antifungal | 25% | Erythromycin | 14.0 mg/mL | | Polysporin | 50% | Ciprofloxacin | 5.4 mg/mL | | Spermicidal Lubricant | 50% | Tums | 31.0 mg/mL | | Penaten/Zinc oxide | 25% | Naproxen | 81.0 mg/mL | | Vagisil | 50% | Imodium | 2.5 mg/mL | aSubstance displayed interference when tested at a higher concentration. bSubstances tested together as a pool. K250358 - Page 20 of 32 {20} Table 7: Microorganisms Tested for Interference | Microorganism | Concentration in Stool Where Interference Not Observed | Microorganism | Concentration in Stool Where Interference Not Observed | | --- | --- | --- | --- | | Master Mix 1 | | | | | Salmonella Typhimurium | >2.00 E+06 CFU/mL | Vibrio parahaemolyticus | >2.00 E+06 CFU/mL | | Campylobacter jejuni | | Bacteroides fragilis | | | Shigella sonnei | | Proteus vulgaris | | | Plesiomonas shigelloides | | Enterobacter aerogenes | | | Yersinia enterocolitica | | Enterobacter cloacae | | | E. coli (sta2) | | Bacteroides vulgatus^{a} | | | Klebsiella pneumoniae | | E. coli (stx1/stx2) | | | Master Mix 2 | | | | | Salmonella Typhimurium | >2.00 E+06 CFU/mL | Vibrio parahaemolyticus | >2.00 E+06 CFU/mL | | Campylobacter jejuni | | Bacteroides fragilis | | | Shigella sonnei | | Proteus vulgaris | | | Plesiomonas shigelloides | | Enterobacter aerogenes | | | Yersinia enterocolitica | | Enterobacter cloacae | | | E. coli (sta2) | | Bacteroides vulgatus^{a} | >2.00 E+05 CFU/mL | | Klebsiella pneumoniae | | E. coli (stx1/stx2) | | aMicroorganism displayed interference when tested at a higher concentration. ## Mixed Infection/Competitive Interference The mixed infection/competitive interference study was designed to evaluate the ability of the BD Enteric Bacterial Panel plus for BD COR System to detect low positive results in the presence of other targets at high concentrations. The study was performed utilizing two target groups on a per master mix basis. For target group one, four organisms (Salmonella Typhimurium, Campylobacter jejuni, Shigella sonnei, and E. coli (stx1-a) were individually prepared at ~2x their respective LoD in negative background stool matrix to serve as a low target. A high target mix comprised of the organisms representative of the other three BD Enteric Bacterial Panel plus for BD COR System analytes was added to the sample at concentrations of ≥1 E+06 CFU/mL. All four low target organisms were successfully detected by the BD Enteric Bacterial Panel plus for BD COR System when combined with their respective simulated high target concentration mixed infection preparations. For target group two, four organisms (Yersinia enterocolitica, Plesiomonas shigelloides, E. coli (sta2), and Vibrio parahaemolyticus) were individually prepared at ~2x their respective LoD in negative background stool matrix to serve as a low target. A high target mix comprised of the organisms representative of the other three BD Enteric Bacterial Panel plus analytes was added to the sample at concentrations of ≥1 E+06 units/mL. Successful detection of all low target concentrations was achieved in the presence of Yersinia enterocolitica (≥1 E+04 CFU/mL) and Vibrio parahaemolyticus (≥1 E+05 cells/mL). ## 4. Assay Reportable Range: K250358 - Page 21 of 32 {21} Not applicable 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Specimen Stability A specimen stability study was conducted to demonstrate stability of organisms targeted by the BD Enteric Bacterial Panel plus for BD COR System using contrived samples prepared at 3X LoD concentrations in BD Fecal Collection and Transport Kit (FCT) preserved stool matrix as well as post-transfer to sample buffer tubes (SBTs) containing BD EBP/EBP plus sample buffer. Results from the stability study support the sample handling and storage claims described in the device labeling. External Controls A study was conducted to verify use of the Microbiologics Helix Elite Extended Enteric Bacterial Verification Panel as an External Positive Control with the BD Enteric Bacterial Panel plus for BD COR system. Uninoculated BD Fecal Collection and Transport Kit tubes were used to verify their use as an External Negative Control. The results demonstrate that the addition of three lyophilized pellets of Microbiologics Helix Elite Extended Enteric Bacterial Verification Panel to a BD Fecal Collection and Transport Kit can be utilized as an External Positive Control for the BD Enteric Bacterial and Enteric. Bacterial Panel plus Panels for BD COR system. Uninoculated BD Fecal Collection and Transport Kit tubes can be used as an External Negative Control with the BD Enteric Bacterial and Enteric Bacterial Panel plus Panels for BD COR system. 6. Detection Limit: The Limit of Detection (LoD) of the BD Enteric Bacterial Panel plus for BD COR System for target analytes in the BD Fecal Collection and Transport Kit was determined as follows: A microbial suspension was prepared from each of two representative strains of the target organisms detected by the BD Enteric Bacterial Panel plus for BD COR System. Each target organism was quantified prior to testing. Positive specimens were prepared by inoculating pooled stool in BD Fecal Collection and Transport Kit with multiple concentrations of each representative strain. Each matrix suspension was tested with at least 20 replicates per concentration using at least 3 BD COR Systems and 3 different lots of the BD Enteric Bacterial Panel plus for BD COR System. Determined LoDs were then confirmed with additional replicates. The LoD, defined as the lowest concentration at which at least 95% of all replicates tested positive, ranged from 116 to 10,705 units/mL (Table 8). Table 8: Limit of Detection of the BD Enteric Bacterial Panel plus Assay | Organism/Strain ID | Catalog Number | Limit of Detection (CFU/mL in FCT)^{a} | | --- | --- | --- | | Salmonella Typhimurium | ATCC 14028 | 923 | | Salmonella enteritidis | ATCC 13076 | 2769 | | Shigella sonnei | ATCC 9390 | 242 | K250358 - Page 22 of 32 {22} | Shigella flexneri | ATCC 700930 | 242 | | --- | --- | --- | | Campylobacter jejuni | ATCC 43429 | 153 | | Campylobacter coli | ATCC 43134 | 116 | | E. coli (STEC; stx1a) | ATCC 43890 | 1077 | | E. coli (STEC; stx2a) | ATCC 43889 | 344 | | Plesiomonas shigelloides | ATCC 14029 | 8269 | | Plesiomonas shigelloides | ATCC 14030 | 936 | | Yersinia enterocolitica | ATCC 9610 | 2385 | | Yersinia enterocolitica | ATCC 49397 | 265 | | E. coli (ETEC; stx2) | ATCC 43896 | 361 | | E. coli (ETEC; sta1, sta2, eltA) | ATCC 35401 | 121 | | Vibrio parahaemolyticus | ATCC 17802 | 207 | | Vibrio cholerae | ATCC 14033 | 149 | | Vibrio vulnificus | ATCC 27562 | 10705 | *LoD concentrations are expressed in CFU/mL, except for Vibrio, which is expressed in cells/mL. 7. Assay Cut-Off: Not applicable B Comparison Studies: 1. Method Comparison with Predicate Device: Not applicable 2. Matrix Comparison: Not applicable C Clinical Studies: Clinical performance characteristics of the BD Enteric Bacterial Panel plus for BD COR System was determined in a multi-site investigational study. The study involved a total of six geographically diverse clinical collection centers where stool specimens were collected as part of routine patient care. Remnant stools were de-identified and enrolled prospectively into the study and tested with BD Enteric Bacterial Panel plus for BD COR System. Specimens were obtained from pediatric or adult patients suspected of acute bacterial gastroenteritis, enteritis, or colitis, for which diagnostic tests had been ordered by a healthcare provider. Three sites performed BD Enteric Bacterial Panel plus for BD COR System testing and/or comparator method testing. Retrospective specimens from a previous study and obtained from specimen vendors were also evaluated. The performance of the BD Enteric Bacterial Panel plus for BD COR System was evaluated in comparison to an FDA-cleared PCR assay for most analytes. For Campylobacter spp., Shiga toxin (stx/stx1/stx2), Vibrio spp., Yersinia enterocolitica, and ETEC performance was compared to a composite comparator method utilizing three different FDA-cleared PCR tests. K250358 - Page 23 of 32 {23} # Study Methods PPA and NPA were estimated with $95\%$ two-sided confidence interval. Point estimates of $90\%$ agreement with lower bound at $85\%$ for highest prevalence targets. # Discrepant Testing Results between the BD Enteric Bacterial Panel plus for BD COR System assay and the reference method were evaluated to determine if specimen results were concordant or discrepant. If discrepant testing was indicated, an aliquot from the unpreserved parent specimen was prepared and shipped to an external site on dry ice or frozen ice packs and stored until it was tested. Specimens were tested according to the Instructions for Use. Only the result of the discrepant analyte was considered. # Repeat Testing Specimens were required to be repeated if a non-reportable result was obtained, or an external positive or negative control had failed to produce the expected result(s). Other situations where repeat testing may have been performed include, but are not limited to, instrument malfunctions, testing level noncompliance, or no valid testing result for either the comparator or evaluator. In order to be as efficient as possible with the specimens collected, specimens that did not have an evaluable pair of results for both the investigational device and reference method due to noncompliance at the testing level were aliquoted and retested during a period from April 2024 through July 2024. Specimens originally collected during the period of November 2022 through July 2023 were tested on both the investigational assay and reference assay even if one method had a valid result. This was to ensure that the specimens were tested under similar conditions. Any valid results from repeated specimens from that period, without a corresponding, comparable result were made non-evaluable. Specimens originally tested from April 2024 through July 2024 were only repeated for the method(s) where no valid result was obtained due to non-compliance. # Clinical Performance for Target Analytes # Salmonella spp. In comparison to a single comparator, the BD EBP for BD COR System detected $94.7\%$ and $99.4\%$ of the Salmonella spp. prospective positive and negative specimens, respectively, and $98.3\%$ and $98.5\%$ of the retrospective positive and negative specimens, respectively (refer to Table 9). Table 9: Salmonella spp. - BD Enteric Bacterial Panel plus Clinical Performance | Salmonella spp. | | | Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 36 | 8a | 44 | | | | Negative | 2b | 1434 | 1436 | | | | Total: | 38 | 1442 | 1480 | | | | PPA: | 94.7% | (82.7% - 98.5%) | | | | | NPA: | 99.4% | (98.9% - 99.7%) | | | Retrospective | 1-20 | Positive | 58 | 2c | 60 | K250358 - Page 24 of 32 {24} K250358 - Page 25 of 32 | | Negative | 1^{d} | 135 | 136 | | --- | --- | --- | --- | --- | | | Total: | 59 | 137 | 196 | | | PPA: | 98.3% | (91.0% - 99.7%) | | | | NPA: | 98.5% | (94.8% - 99.6%) | | $^{a}$ Salmonella was detected in 1 of the 8 FP specimens when tested with an independent molecular method. $^{b}$ Salmonella was not detected in 1 of 2 FN specimens when tested with an independent molecular method. $^{a}$ Salmonella was not detected in both FP specimens when tested with an independent molecular method. $^{a}$ Salmonella was not detected in the FN specimen when tested with an independent molecular method. ## Campylobacter spp. (C. jejuni and C. coli) In comparison to a composite comparator, the BD EBP for BD COR System identified 100% and 99.4% of the Campylobacter jejuni and C. coli prospective positive and negative specimens, respectively, and 100% of the retrospective positive and negative specimens (Table 10) when compared to a two out of three composite comparator method. Table 10: Campylobacter (C. jejuni and C. coli) - BD Enteric Bacterial Panel plus Clinical Performance | Campylobacter | | | Composite Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 32 | 3^{a} | 35 | | | | Negative | 0^{b} | 463^{c} | 463 | | | | Total: | 32 | 466 | 498 | | | | PPA: | 100.0% | (89.3% - 100.0%) | | | | | NPA: | 99.4% | (98.1% - 99.8%) | | | Retrospective | Frozen | Positive | 67 | 0 | 67 | | | | Negative | 0 | 73^{c} | 73 | | | | Total: | 67 | 73 | 140 | | | | PPA: | 100.0% | (94.6% - 100.0%) | | | | | NPA: | 100.0% | (95.0% - 100.0%) | | $^{a}$ Campylobacter was detected in all 3 FP specimens with one of the three comparator methods. $^{b}$ One specimen negative for Campylobacter with BD Enteric Bacterial Panel but positive with the single FDA-cleared comparator was excluded because the parent tube was no longer available and complete composite comparator testing could not be obtained. $^{c}$ The sample size for NPA is smaller for Campylobacter spp. (C. jejuni and C. coli) as only a portion of the specimens with a negative result in BD Enteric Bacterial Panel and with the single FDA-cleared comparator was tested with the complete composite comparator in the prospective and retrospective studies. ## Shigella spp. / EIEC In comparison to a single comparator, the BD EBP for BD COR System detected 80.0% and 100% of the Shigella spp. / EIEC prospective positive and negative specimens, respectively, and 94.4% and 98.8% of the retrospective positive and negative specimens, respectively (Table 11). Table 11: Shigella spp. / EIEC – BD Enteric Bacterial Panel plus Clinical Performance | Shigella | | | Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 12 | 0 | 12 | | | | Negative | 3^{a} | 1464 | 1467 | {25} K250358 - Page 26 of 32 | | | Total: | 15 | 1464 | 1479 | | --- | --- | --- | --- | --- | --- | | | | PPA: | 80.0% | (54.8% - 93.0%) | | | | | NPA: | 100.0% | (99.7% - 100.0%) | | | Retrospective | Frozen | Positive | 34 | 2^{b} | 36 | | | | Negative | 2^{c} | 158 | 160 | | | | Total: | 36 | 160 | 196 | | | | PPA: | 94.4% | (81.9% - 98.5%) | | | | | NPA: | 98.8% | (95.6% - 99.7%) | | $^{a}$ Shigella spp./EIEC was not detected in the 3 FN specimens when tested with an independent molecular method. $^{b}$ Shigella spp./EIEC was not detected in both FP specimens when tested with an independent molecular method. $^{c}$ Shigella spp./EIEC was not detected in 1 of the 2 FN specimens when tested with an independent molecular method. ## Shiga toxin-producing E. coli (stx/stx1/stx2 genes) In comparison to a composite comparator, the BD EBP for BD COR System detected 100% and 99.8% of the Shiga toxin (stx/stx1/stx2 genes) prospective positive and negative specimens, respectively, and 100% of the retrospective positive and negative specimens (Table 12). Table 12: Shiga toxin-producing E. coli (stx/stx1/stx2 genes) – BD Enteric Bacterial Panel plus Composite Comparator Clinical Performance | Shiga toxin-producing E. coli | | | Composite Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 10^{a} | 1 | 11 | | | | Negative | 0 | 489^{b} | 489 | | | | Total: | 10 | 490 | 500 | | | | PPA: | 100.0% | (72.3% - 100.0%) | | | | | NPA: | 99.8% | (98.9% - 100.0%) | | | Retrospective | Frozen | Positive | 9 | 0 | 9 | | | | Negative | 0 | 130^{b} | 130 | | | | Total: | 9 | 130 | 139 | | | | PPA: | 100.0% | (70.1% - 100.0%) | | | | | NPA: | 100.0% | (97.1% - 100.0%) | | $^{a}$ One specimen positive for Shiga toxin with BD EBP plus and the single FDA-cleared comparator was excluded because the parent tube was no longer available and complete composite comparator testing could not be obtained. $^{b}$ The sample size for NPA is smaller for Shiga toxin as only a portion of the specimens with a negative result with BD EBP plus and with the single FDA-cleared comparator was tested with the complete composite comparator in the prospective and retrospective studies. As Shiga toxin (stx/stx1/stx2 genes) prevalence was low, an evaluation of contrived specimens was performed to supplement the data collected in the study (Table 13). Table 13: Shiga toxin-producing E. coli (stx/stx1/stx2 genes) – Contrived Specimen Performance | Shiga toxins | Expected Result | | Total | | --- | --- | --- | --- | | | Positive | Negative | | | Positive | 50 | 0 | 50 | {26} | Negative | 0 | 250 | 250 | | --- | --- | --- | --- | | Total: | 50 | 250 | 300 | | PPA: | 100.0% | (92.9% - | 100.0%) | | NPA: | 100.0% | (98.5% - | 100.0%) | # Plesiomonas shigelloides In comparison to a single comparator, the BD EBP for BD COR System detected $66.7\%$ and $100\%$ of the Plesiomonas shigelloides prospective positive and negative specimens, respectively, and $100\%$ of the retrospective positive and negative specimens (Table 14). Table 14: Plesiomonas shigelloides - BD Enteric Bacterial Panel plus Clinical Performance | Plesiomonas shigelloides | | | Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 2 | 0 | 2 | | | | Negative | 1a | 1484 | 1485 | | | | Total: | 3 | 1484 | 1487 | | | | PPA: | 66.7% | (20.8% - 93.9%) | | | | | NPA: | 100.0% | (99.7% - 100.0%) | | | Retrospective | Frozen | Positive | 2 | 0 | 2 | | | | Negative | 0 | 195 | 195 | | | | Total: | 2 | 195 | 197 | | | | PPA: | 100.0% | (34.2% - 100.0%) | | | | | NPA: | 100.0% | (98.1% - 100.0%) | | ${}^{a}$ One specimen could not be tested with an independent molecular method. As Plesiomonas shigelloides prevalence was low, an evaluation of contrived specimens was performed to supplement data collected in the study (Table 15). Table 15: Plesiomonas shigelloides - Contrived Specimens Results | Plesiomonas shigelloides | Expected Result | | Total | | --- | --- | --- | --- | | | Positive | Negative | | | Positive | 50 | 0 | 50 | | Negative | 0 | 250 | 250 | | Total: | 50 | 250 | 300 | | PPA: | 100.0% | (92.9% - 100.0%) | | | NPA: | 100.0% | (98.5% - 100.0%) | | # Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae) In comparison to a composite comparator, the BD EBP for BD COR System identified $100\%$ of the Vibrio spp. prospective positive and negative specimens, and $100\%$ of the retrospective negative specimens (Table 16). K250358 - Page 27 of 32 {27} Table 16: Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae) – BD Enteric Bacterial Panel plus Clinical Performance | Vibrio spp. | | | Composite Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 2 | 0 | 2 | | | | Negative | 0 | 501^{a} | 501 | | | | Total: | 2 | 501 | 503 | | | | PPA: | 100.0% | (34.2% - 100.0%) | | | | | NPA: | 100.0% | (99.2% - 100.0%) | | | Retrospective | Frozen | Positive | 0 | 0 | 0 | | | | Negative | 0 | 140 | 140 | | | | Total: | 0 | 140 | 140 | | | | NPA: | 100.0% | (97.3% - 100.0%) | | aThe sample size for NPA is smaller for Vibrio spp. as only a portion of the specimens with a negative result with BD EBP plus and with the single FDA-cleared comparator was tested with the complete composite comparator in the prospective and retrospective studies. As Vibrio spp. prevalence was low, an evaluation of contrived specimens was performed to supplement data collected in the study (Table 17). Table 17: Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae) – Contrived Specimens Results | Vibrio spp. | Expected Result | | Total | | --- | --- | --- | --- | | | Positive | Negative | | | Positive | 48 | 0 | 48 | | Negative | 2 | 250 | 252 | | Total: | 50 | 250 | 300 | | PPA: | 96.0% | (86.5% - 98.9%) | | | NPA: | 100.0% | (98.5% - 100.0%) | | # ETEC (Heat-Labile Enterotoxin (LT) / Heat-Stable Enterotoxin (ST) Genes) In comparison to a composite comparator, the BD EBP for BD COR System identified 70.6% and 99.8% of the ETEC prospective positive and negative specimens, respectively, and 100% and 99.2% of the retrospective positive and negative specimens, respectively (Table 18). Table 18: ETEC (Heat-Labile Enterotoxin (LT) / Heat-Stable Enterotoxin (ST) Genes) – BD Enteric Bacterial Panel plus Composite Comparator Clinical Performance | ETEC | | | Composite Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Fresh | Positive | 9 | 1^{a} | 10 | | | | Negative | 1^{b} | 240^{c} | 241 | | | | Total: | 10 | 241 | 251 | K250358 - Page 28 of 32 {28} | | | PPA: | 90.0% | (59.6% | - | 98.2%) | | --- | --- | --- | --- | --- | --- | --- | | | | NPA: | 99.6% | (97.7% | - | 99.9%) | | Prospective | Frozen | Positive | 3 | 0 | | 3 | | | | Negative | 4d | 246e | | 250 | | | | Total: | 7 | 246 | | 253 | | | | PPA: | 42.9% | (15.8% | - | 75.0%) | | | | NPA: | 100.0% | (98.5% | - | 100.0%) | | Retrospective | Frozen | Positive | 13 | 1b | | 14 | | | | Negative | 0 | 246e | | 246 | | | | Total: | 13 | 247 | | 260 | | | | PPA: | 100.0% | (77.2% | - | 100.0%) | | | | NPA: | 99.6% | (97.7% | - | 99.9%) | aETEC was detected in the FP specimen with one of the three comparator methods in the prospective and retrospective studies. bETEC was not detected in the FN specimen with one of the three comparator methods. The sample size for NPA is smaller for ETEC as only a portion of the specimens with a negative result with COR EBP plus and with the single FDA-cleared comparator was tested with the complete composite comparator in the prospective and retrospective studies. dETEC was not detected in all 4 FN specimens with one of the three comparator methods. As ETEC prevalence was low, an evaluation of contrived specimens was performed to supplement data collected in the study (Table 19). Table 19: ETEC (Heat-Labile Enterotoxin (LT) / Heat-Stable Enterotoxin (ST) Genes) - Contrived Specimens Results | ETEC | Expected Result | | Total | | --- | --- | --- | --- | | | Positive | Negative | | | Positive | 50 | 0 | 50 | | Negative | 0 | 250 | 250 | | Total: | 50 | 250 | 300 | | PPA: | 100.0% | (92.9% - | 100.0%) | | NPA: | 100.0% | (98.5% - | 100.0%) | # Yersinia enterocolitica In comparison to a composite comparator, the BD EBP for BD COR System identified $100\%$ of the Y. enterocolitica prospective positive and negative specimens, and $100\%$ of the retrospective positive and negative specimens (Table 20). Table 20: Yersinia enterocolitica - BD Enteric Bacterial Panel plus Clinical Performance | Yersinia enterocolitica | | | Composite Comparator | | Total | | --- | --- | --- | --- | --- | --- | | Specimen | | BD COR | Positive | Negative | | | Prospective | Combined Fresh + Frozen | Positive | 4 | 0 | 4 | | | | Negative | 0a | 497b | 497 | | | | Total: | 4 | 497 | 501 | | | | PPA: | 100.0% | (51.0% - 100.0%) | | | | | NPA: | 100.0% | (99.2% - 100.0%) | | | Retrospective | Frozen | Positive | 2 | 0 | 2 | K250358 - Page 29 of 32 {29} | | Negative | 0 | 138b | 138 | | --- | --- | --- | --- | --- | | | Total: | 2 | 138 | 140 | | | PPA: | 100.0% | (34.2% | - 100.0%) | | | NPA: | 100.0% | (97.3% | - 100.0%) | ${}^{a}$ One specimen negative for Yersinia enterocolitica with BD EBP plus and positive with the single FDA-cleared comparator was excluded because two comparators of the composite comparator disagreed and the specimen for the tiebreaker was non-compliant. One specimen negative for Y. enterocolitica with BD EBP plus and positive with the single FDA-cleared comparator was excluded because two comparators of the composite disagreed, and the tiebreaker gave a final non-reportable result. bThe sample size for NPA is smaller for Yersinia enterocolitica as only a portion of the specimens with a negative result with COR EBP plus and with the single FDA-cleared comparator was tested with the composite comparator in the prospective and retrospective studies. As Yersinia enterocolitica prevalence was low, an evaluation of contrived specimens was performed to supplement data collected in the study (Table 21). Table 21: Yersinia enterocolitica - Contrived Specimens Results | Yersinia enterocolitica | Expected Result | | Total | | --- | --- | --- | --- | | | Positive | Negative | | | Positive | 50 | 0 | 50 | | Negative | 0 | 250 | 250 | | Total: | 50 | 250 | 300 | | PPA: | 100.0% | (92.9% - | 100.0%) | | NPA: | 100.0% | (98.5% - | 100.0%) | # Non-Reportable Results for BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System Non-reportable results were defined as results obtained while assessing the BD Enteric Bacterial Panel plus for BD COR System targets with the BD Enteric Bacterial Panel plus assay on BD COR System which resulted in a sample processing control or system failure. A failure may also occur when the External Control produces an unexpected result such as an External Positive Control that produces a negative result or an External Negative Control that produces a positive result. For non-reportable rate calculations, the specimen and the BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System must be compliant to qualify the data included in the calculation for the denominator of the UNR/IND/INC rate. A UNR is counted in the numerator only if it is specimen compliant, BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System compliant, and External Controls yield expected results. External Controls are not considered for IND/INC numerator calculations. Non-reportable rates with BD Enteric Bacterial Panel for BD COR System and BD Enteric Bacterial Panel plus for BD COR System are shown in Table 22 and Table 23, respectively. Table 22: Summary of BD Enteric Bacterial Panel for BD COR System Total Non-Reportable Rate for Combined Targets K250358 - Page 30 of 32 {30} K250358 - Page 31 of 32 | Combined EBP plus Targets | Unresolved Rate | | Indeterminate Rate | | Incomplete Rate | | Total UNR+IND+INC Rate | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Specimen Origin | Initial (95% CI) | Finala (95% CI) | Initial (95% CI) | Finala (95% CI) | Initial (95% CI) | Finala (95% CI) | Initial (95% CI) | Finala (95% CI) | | Prospective | 3.1% | 1.6% | 0.1% | 0.0% | 0.1% | 0.0% | 3.3% | 1.6% | | | 47/1537 | 24/1514 | 1/1537 | 0/1514 | 2/1537 | 0/1514 | 50/1537 | 24/1514 | | | (2.3%, 4.0%) | (1.1%, 2.3%) | (0.0%, 0.4%) | (0.0%, 0.2%) | (0.0%, 0.5%) | (0.0%, 0.2%) | (2.5%, 4.3%) | (1.1%, 2.3%) | | Retrospective | 3.0% | 2.0% | 0.0% | 0.0% | 0.0% | 0.0% | 3.0% | 2.0% | | | 6/200 | 4/200 | 0/200 | 0/200 | 0/200 | 0/200 | 6/200 | 4/200 | | | (1.4%, 6.4%) | (0.8%, 5.0%) | (0.0%, 1.9%) | (0.0%, 1.9%) | (0.0%, 1.9%) | (0.0%, 1.9%) | (1.4%, 6.4%) | (0.8%, 5.0%) | aThe final rate is calculated with valid repeats only. Table 23: Summary of BD Enteric Bacterial Panel plus for BD COR System Total Non-Reportable Rate for Combined Targets | Combined EBP plus Targets | Unresolved Rate | | Indeterminate Rate | | Incomplete Rate | | Total UNR+IND+INC Rate | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Specimen Origin | Initial (95% CI) | Finala (95% CI) | Initial (95% CI) | Finala (95% CI) | Initial (95% CI) | Finala (95% CI) | Initial (95% CI) | Finala (95% CI) | | Prospective | 4.9% | 1.8% | 10.0% | 0.0% | 10.0% | 0.0% | 5.1% | 1.8% | | | 76/1537 | 28/1514 | 1/1537 | 0/1514 | 2/1537 | 0/1514 | 79/1537 | 28/1514 | | | (4.0%, 6.1%) | (1.3%, 2.6%) | 0.0%, 0.4%) | (0.0%, 0.2%) | (0.0%, 0.5%) | (0.0%, 0.2%) | (4.1%, 6.4%) | (1.3%, 2.6%) | | Retrospective | 4.5% | 3.0% | 0.0% | 0.0% | 0.0% | 0.0% | 4.5% | 3.0% | | | 9/200 | 6/200 | 0/200 | 0/200 | 0/200 | 0/200 | 9/200 | 6/200 | | | (2.4%, 8.3%) | (1.4%, 6.4%) | (0.0%, 1.9%) | (0.0%, 1.9%) | (0.0%, 1.9%) | (0.0%, 1.9%) | (2.4%, 8.3%) | (1.4%, 6.4%) | aThe final rate is calculated with valid repeats only. ## D Clinical Cut-Off: Not applicable ## E Expected Values/Reference Range: A total of 1682 prospective remnant specimens and 235 retrospectively collected specimens to total of 1,917 specimens were included in this study. Of these, 110 specimens did not meet inclusion/exclusion criteria, had inadequate source documentation, specimen handling errors, or were outside of stability leaving a total of 1807 specimens compliant for testing. After exclusion of specimens due to testing non-compliance (79) and final non-reportable results, a total of 1493 prospective and 200 retrospective specimens were evaluable with the BD Enteric Bacterial Panel plus for BD COR System and the comparator method with at least one target included into the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) calculations. The number and percentage of positive cases per target, as determined by the BD EBP plus for BD COR System, are presented in Table 24 below. {31} Table 24: Positivity Rate Among Prospective Specimens for BD EBP plus Targets by Collection Site | Collection Site | Salmonella | Campylobacter | Shigella /EIEC | Shiga toxin | Plesiomonas shigelloides | Vibrio | ETEC | Yersinia enterolitica | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | 4.9% (4/81) | 3.7% (3/81) | 0.0% (0/81) | 4.9% (4/82) | 1.2% (1/83) | 0.0% (0/83) | 0.0% (0/83) | 0.0% (0/83) | | 2 | 4.7% (12/258) | 2.7% (7/259) | 0.0% (0/258) | 0.8% (2/259) | 0.0% (0/262) | 0.8% (2/262) | 0.8% (2/262) | 0.0% (0/262) | | 3 | 4.4% (2/45) | 0.0% (0/45) | 0.0% (0/45) | 2.2% (1/45) | 2.2% (1/46) | 0.0% (0/46) | 2.2% (1/46) | 0.0% (0/46) | | 4 | 0.8% (4/483) | 0.4% (2/483) | 0.8% (4/483) | 0.4% (2/484) | 0.0% (0/486) | 0.0% (0/486) | 0.4% (2/486) | 0.4% (2/486) | | 5 | 1.3% (3/226) | 1.8% (4/226) | 0.0% (0/226) | 0.4% (1/226) | 0.0% (0/227) | 0.0% (0/227) | 0.0% (0/227) | 0.4% (1/227) | | 6 | 4.8% (19/396) | 4.8% (19/396) | 2.0% (8/395) | 0.5% (2/396) | 0.0% (0/392) | 0.0% (0/392) | 2.0% (8/393) | 0.3% (1/392) | | Subtotal | 3.0% (44/1,489) | 2.3% (35/1,490) | 0.8% (12/1,488) | 0.8% (12/1,492) | 0.1% (2/1,496) | 0.1% (2/1,496) | 0.9% (13/1,497) | 0.3% (4/1,496) | VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K250358 - Page 32 of 32
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