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BD Enteric Bacterial Panel for BD COR™ System

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

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.

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.

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.

The BD COR™ System is comprised of a single BD COR™ PX System attached to a BD COR™ MX Analyzer as described in 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.

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The BD CTGCTV2 assay incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:

• Chlamydia trachomatis (CT)
• Neisseria gonorrhoeae (GC)
• Trichomonas vaginalis (TV)

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting) and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in ThinPrep® PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep® Pap test. The assay may also be used for the detection of CT and GC DNA in clinician-collected rectal and oropharyngeal swab specimens.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection.

The BD CTGCTV2 assay is available for use with the BD MAX™ System (urogenital specimens) or the BD COR™ System (urogenital and extragenital specimens), as described above.

The BD CTGCTV2 assay, performed on the BD COR™ System (hereafter referred to as BD CTGCTV2), is designed for use with the applicable BD Molecular specimen collection and transport devices for male and female urine, rectal swabs, oropharyngeal swabs, vaginal swabs, endocervical swabs, and LBC specimens (PreservCyt®). Specimens are collected and transported to the testing laboratory using their respective transport devices under conditions of time and temperature that have been determined to maintain the integrity of the target nucleic acids.

The BD COR™ MX Instrument, when combined with the BD COR™ PX Instrument, is to be used for automated sample preparation, extraction, and purification of nucleic acids from multiple specimen types, 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 Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

The BD CTGCTV2 assay extraction reagents are dried in 96-well microtiter plates that contain binding magnetic affinity beads and Sample Processing Control (SPC). Each tube 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 CTGCTV2 assay liquid reagent plate includes Wash, Elution and Neutralization buffers. The beads (described above), together with the bound nucleic acids, are washed and the nucleic acids are eluted by a combination of heat and pH. When performed on BD COR™ System, there is an additional buffer to rehydrate the dried extraction mix. Eluted DNA is neutralized and transferred to the Amplification reagent (described below) to rehydrate the PCR reagents. 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 thus prevent evaporation and contamination.

The BD CTGCTV2 assay is comprised of two targets for Chlamydia trachomatis (detected on the same optical channel), two targets for Neisseria gonorrhoeae (detected on two different optical channels) and one target for Trichomonas vaginalis (detected on one optical channel). Only one Chlamydia trachomatis target is required to be positive in order to report a positive result. Both Neisseria gonorrhoeae targets are required to be positive in order to report a positive result.

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).

The provided FDA 510(k) clearance letter and summary for the BD CTGCTV2 assay detail its performance in detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in extragenital specimens (rectal and oropharyngeal swabs).

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Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BD CTGCTV2 assay are implicitly demonstrated through its clinical performance results, where the assay's sensitivity (Positive Percent Agreement - PPA) and specificity (Negative Percent Agreement - NPA) for extragenital specimens are compared against a Composite Comparator Algorithm (CCA). The FDA's clearance indicates that these performance metrics met the necessary standards for substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

While explicit numerical acceptance criteria (e.g., "PPA must be >= X%") are not directly stated in the provided text, the reported performance measures are the ones that met the FDA's requirements for clearance.

Study that Proves the Device Meets the Acceptance Criteria:

The key study proving the device meets the acceptance criteria is the Clinical Performance Study for Extragenital Specimens.

1. Sample Size Used for the Test Set and Data Provenance:

• Total Subjects Consented: 2,439
• Eligible Subjects: 2,375
• Total Eligible Specimens (test set): 4,652 (oropharyngeal and rectal swabs, considered for randomization)
• Eligible Specimens for Testing: 4,579 (2,303 oropharyngeal swabs and 2,276 rectal swabs)
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the mention of "eight geographically diverse sites" suggests a multi-site clinical study, likely within the US, given FDA clearance.
  • Retrospective or Prospective: Prospective, as specimens were collected from subjects enrolled in the study. The study involved consenting subjects and collecting specimens specifically for this evaluation.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document.
• The ground truth was established by a Composite Comparator Algorithm (CCA), not direct human expert interpretation of images or other subjective data.

3. Adjudication Method for the Test Set:

• The adjudication method used for the ground truth (CCA) was based on the concurrence of at least 2 out of 3 commercially available NAAT assays. This means it was a "2 out of 3" agreement model for establishing the positive or negative status of a specimen.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is a fully automated in vitro diagnostic (IVD) assay that detects nucleic acids, not an AI-assisted imaging device requiring human interpretation. Therefore, the concept of "human readers improving with AI assistance" does not apply.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, this was a standalone performance study. The BD CTGCTV2 assay is an automated system (BD COR™ System) that performs sample preparation, extraction, amplification, and detection. Its performance "without human-in-the-loop" is precisely what the clinical performance study measures, specifically in comparison to a CCA, which also represents an objective, algorithm-based comparator.

6. The Type of Ground Truth Used:

• The ground truth used was a Composite Comparator Algorithm (CCA), consisting of results from three commercially available Nucleic Acid Amplification Tests (NAATs).

7. The Sample Size for the Training Set:

• The document does not specify the sample size for the training set. The provided clinical performance data (4,579 specimens) pertains to the test set used for validation. Given that this is an IVD assay, the "training" analogous to machine learning would relate to the development and optimization of the assay's reagents, protocols, and analytical parameters, rather than a distinct "training set" of patient data in the typical sense of AI/ML model development.

8. How the Ground Truth for the Training Set Was Established:

• As the document does not explicitly discuss a "training set" in the context of machine learning, it also does not describe how a ground truth for such a set was established. For an IVD assay, the "ground truth" during development (analogous to training) would typically involve well-characterized reference strains, spiked samples with known concentrations, and analytical validation studies to optimize assay parameters, which are alluded to in the "Analytical Performance Evaluation" section (e.g., LoD, Inclusivity, Cross-Reactivity, Microbial Interference).

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