(210 days)
BD MAX™ Enteric Bacterial Panel
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™ Enterial Panel detects nucleic acids from:
- · Salmonella spp.
- · Campylobacter spp. (jejuni and coli)
- · Shigella spp. / Enteroinvasive E. coli (EIEC)
· Shiga toxin 1 (stxl ) / 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 diartheal stool specimens or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis 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 strilstr2. The test utilizes fluorogenic sequence-specific hybridization 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 toxinproducing 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 noninfectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
BD MAX™ Extended Enteric Bacterial Panel
The BD MAX™ Extended 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. 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 diar preserved stool specimens from symptomatic patients with suspected acute gastroenteritis 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 genespecific hybridization probes for the 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 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 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 BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays along with the BD MAX System are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis. DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. For the BD MAXTM Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.
This document describes the performance evaluation of the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel when used with the BD FecalSwab™ Collection, Transport and Preservation System. The primary goal of the studies was to demonstrate substantial equivalence to the existing Cary-Blair Para-Pak® specimen collection method.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria varied across the different studies. For the user variability study, specific percentage targets were set. For the clinical evaluation, the performance was presented as Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to the Cary-Blair method.
User Variability Study Acceptance Criteria and Performance:
| Target | Panel Member | Acceptance Criteria | Assay Results | Result |
|---|---|---|---|---|
| Campylobacter jejuni and ETEC | Moderate-Positive | 100% POS | 100% POS | Pass |
| Campylobacter jejuni and ETEC | Low-Positive | ≥ 95% POS | 100% POS | Pass |
| Negative samples | Negative | 100% NEG | 100% NEG | Pass |
Clinical Evaluation Performance (FecalSwab™ vs. Cary-Blair):
| Pathogen | Specimen Origin | Positive Percent Agreement (PPA) | Negative Percent Agreement (NPA) |
|---|---|---|---|
| Campylobacter spp. | Prospective | 100.0% | 99.8% |
| Retrospective | 100.0% | 97.1% | |
| Salmonella spp. | Prospective | 100.0% | 100.0% |
| Retrospective | 93.3% | 95.9% | |
| Shigella spp. | Prospective | 100.0% | 100.0% |
| Retrospective | 98.1% | 99.6% | |
| stx1/stx2 (STX) | Prospective | 100.0% | 99.5% |
| Retrospective | 92.9% | 100.0% | |
| stx1/stx2 (STX) | Contrived | 100.0% | 100.0% |
| Plesiomonas shigelloides | Prospective | 100.0% | 99.0% |
| Retrospective | 33.3% * | 100.0% | |
| Plesiomonas shigelloides | Contrived | 100.0% | 100.0% |
| Vibrio spp. | Prospective | Not Available | 99.7% |
| Retrospective | 100.0% | 100.0% | |
| Vibrio spp. | Contrived | 98.1% | 100.0% |
| ETEC | Prospective | 100.0% | 100.0% |
| Retrospective | 100.0% | 99.6% | |
| ETEC | Contrived | 100.0% | 100.0% |
| Yersinia enterocolitica | Prospective | Not Available | 100.0% |
| Retrospective | 100.0% | 99.0% | |
| Yersinia enterocolitica | Contrived | 98.1% | 100.0% |
2. Sample Size for the Test Set and Data Provenance
-
Limiting Dilution LoD Study:
- Test Set Sample Size: For each organism and each collection type (FecalSwab and Para-Pak®), 24 replicates were tested per concentration level. For Plesiomonas shigelloides, Y. enterocolitica, V. parahaemolyticus, and E. coli ETEC, one non-reportable sample in the Para-Pak® group for Conc 1 resulted in 23 replicates.
- Data Provenance: Not explicitly stated, but likely laboratory-prepared samples.
-
User Variability Study:
- Test Set Sample Size: 12 negative samples (6 users x 2 samples), 36 low-positive samples (6 users x 2 samples x 3 panel members), and 12 moderate-positive samples (6 users x 2 samples x 1 panel member).
- Data Provenance: Laboratory-prepared FecalSwab specimens.
-
Clinical Evaluation:
- Test Set Sample Size: 618 prospective specimens and 295 retrospective specimens were initially enrolled (Total 913). After exclusions, the final data analysis included 897 compliant subjects.
- Data Provenance:
- Country of Origin: Not explicitly stated, but collected from "eight (8) geographically diverse clinical centers" which typically implies within the United States for FDA submissions.
- Retrospective/Prospective: Both. 618 prospective specimens and 295 retrospective specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
For these in vitro diagnostic assays, the "ground truth" for the clinical evaluation is based on the results from the predicate device (Cary-Blair Para-Pak® preserved stool samples tested with the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel). No human "experts" like radiologists are mentioned for establishing ground truth in this context; instead, it relies on an established laboratory method.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the sense of expert review for discrepancies between the FecalSwab and Cary-Blair results. The comparison is a direct statistical agreement between the two methods (FecalSwab vs. Cary-Blair). For contrived specimens, the ground truth was "expected results," implying a predefined status based on specimen preparation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test, not an AI imaging or diagnostic algorithm that humans would interpret in a multi-reader, multi-case setting. The evaluation focuses on the analytical and clinical performance of the assay itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (BD MAX™ System with the assay panels) operates in a standalone manner. The test is "automated" and produces qualitative results (POS, NEG, UNR) directly. No human interpretation of the assay results is detailed as part of the core performance, other than the system software interpreting the results.
7. The Type of Ground Truth Used
- Limiting Dilution LoD Study: The ground truth was based on the known concentration of serially diluted organisms spiked into negative stool.
- User Variability Study: The ground truth was based on the known status (negative, low-positive, moderate-positive) of laboratory-prepared panel members.
- Clinical Evaluation: The ground truth for comparing the FecalSwab™ system was the results obtained from the predicate device method (Cary-Blair Para-Pak® preserved stool samples tested with the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel). For the additional contrived specimens, the ground truth was the "expected results" (known positive or negative status of the prepared specimens).
8. The Sample Size for the Training Set
The provided text describes performance evaluation studies for substantial equivalence, focusing on validating the FecalSwab collection method. It does not mention a "training set" in the context of machine learning or AI development. The BD MAX™ assays are PCR-based in vitro diagnostic tests, which typically do not involve machine learning training sets in the same way an AI algorithm might. Their "training" or development would involve optimizing primers, probes, and reaction conditions through laboratory experiments.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the AI sense is explicitly mentioned or relevant for this type of IVD device, this question is not applicable. The development of the assay's ability to detect specific nucleic acids relies on molecular biology principles and analytical validation, not statistical training on labeled data in the way an AI model is trained.
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Becton, Dickinson and Company Joseph Basore Staff Regulatory Specialist 7 Loveton Circle Sparks, Maryland 21152
July 28, 2022
Re: K214122
Trade/Device Name: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay Regulatory Class: Class II Product Code: PCI, PCH, OOI Dated: December 22, 2021 Received: December 30, 2021
Dear Joseph Basore:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214122
Device Name
BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel
Indications for Use (Describe) BD MAX™ Enteric Bacterial Panel
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™ Enterial Panel detects nucleic acids from:
- · Salmonella spp.
- · Campylobacter spp. (jejuni and coli)
- · Shigella spp. / Enteroinvasive E. coli (EIEC)
· Shiga toxin 1 (stxl ) / 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 diartheal stool specimens or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis 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 strilstr2. The test utilizes fluorogenic sequence-specific hybridization 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 toxinproducing 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 noninfectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
BD MAX™ Extended Enteric Bacterial Panel
The BD MAX™ Extended 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. 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 diar preserved stool specimens from symptomatic patients with suspected acute gastroenteritis 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 genespecific hybridization probes for the detection of the amplified DNA.
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This test is intended for 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel
Summary Preparation Date:
12/22/2021
Submitted by:
Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Contact:
Joseph Basore, Ph.D., RAC Staff Regulatory Affairs Specialist Tel: 616-301-4068 Email: Joseph.Basore@bd.com
Proprietary Names:
For the instrument:
BD MAX™ System
For the assay:
BD MAX™ Enteric Bacterial Panel BD MAXTM Extended Enteric Bacterial Panel
Common Names:
For the instrument:
Bench-top molecular diagnostics workstation
For the assay:
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System Enteric Bacterial Panel Enteric Bacterial Nucleic Acid Test Enteric Bacterial identification and differentiation system Enteric assay Enteric test
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Regulatory Information
Regulation section: 21 CFR 866.3990 - Gastrointestinal Panel Multiplex Nucleic Acid-Based Assay System
Classification: Class II (Special Controls)
Panel: Microbiology (83)
Product Code(s):
- PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
- PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Real Time Nucleic Acid Amplification System OOI
Predicate Device
BD MAXTM Enteric Bacterial Panel (K140111) BD MAXTM Extended Enteric Bacterial Panel (K170308)
Device Establishment
Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Registration Number: 1119779
Performance Standards
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.
Intended Use
BD MAX™ Enteric Bacterial Panel
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 nucleic acids from:
- . Salmonella spp.
- . Campylobacter spp. (jejuni and coli)
- Shigella spp. / Enteroinvasive E. coli (EIEC)
- . Shiga toxin 1 (stx/) / 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.
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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 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.
BD MAX™ Extended Enteric Bacterial Panel
The BD MAX™ Extended 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. 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 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
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test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
Special Conditions for Use Statement: For Prescription Use Only
Special Instrument Requirements: BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel are performed on the BD MAX™ System
Device Description
The BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays along with the BD MAX System are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis. DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. For the BD MAXTM Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.
Test Principle
The BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays are designed for use with unpreserved or Cary-Blair preserved stool samples. Unpreserved samples are placed in a BD MAX sample buffer tube (SBT) with a 10 uL transfer loop for analysis on the BD Max System. The current Cary-Blair preserved specimen claim utilizes a plastic paddle (scoop) to place a stool sample into 15 ml of Cary-Blair media for transport before being placed into a SBT with a 10 µL transfer loop prior to analysis on the BD Max System.
To use the FecalSwab Collection, Transport, and Preservation System, the operator transfers fecal material from an unpreserved stool specimen to the vial of FecalSwab transport medium using the nylon flocked specimen collection swab. The FecalSwab transport medium tube is filled with 2 ml of a semi-solid modified Cary-Blair medium that is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory. Last, before analysis on the BD MAX system. samples collected/stored with the FecalSwab system are vortexed and then pipetted (50 µl) into a BD MAX™ sample buffer tube (SBT).
Once specimens (Unpreserved, Cary-Blair, or FecalSwab Cary-Blair) are placed into a BD MAX SBT, the test principles are as described in K140111 and K170308. For all specimen types the SBTs are vortexed and then loaded into the BD MAX system along with the Unitized Reagent Strips, Master Mix, Extraction Tubes, and PCR Cartridges. No further operator intervention is necessary, and the following automated procedures occur. The microbial cells are lysed and DNA
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is extracted using a combination of lytic and extraction reagents at elevated temperatures. Nucleic acids released from the target organisms are captured on magnetic affinity beads. 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 Master Mix Tube to rehydrate the PCR reagents. After reconstitution, the BD MAX System dispenses a fixed volume of PCR-ready solution containing the extracted nucleic acids into the PCR Cartridge. Microvalves in the cartridge are sealed by the system prior to initiating PCR in order to contain the amplification mixture and thus 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 MAX System. The probes are used to detect amplicons for enteric bacterial targets and the Sample Processing Control in five different optical channels of the BD MAX 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 amount of fluorescence detected in the optical channels used for the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays are directly proportional to the quantity of the corresponding probe that is hydrolyzed. The BD MAX 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 assay includes a Sample Processing Control, which monitors the integrity of the reagents as well as the process steps involved in DNA extraction, amplification and detection, and checks for the presence of potential assay inhibitor.
Substantial Equivalence1
Table 1 and Table 2 provides the similarities and differences between the submitted device and the legally marketed predicate device.
The term "substantial equivalence" as used in this 510(1) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended ander 21 CFR 807, Subpat E under which a device can be marketed without pre-market approval or reclassification of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or the courts.
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| Comparison of BD MAX™ Enteric Bacterial Panel to Predicate DeviceTable 1: | |
|---|---|
| ------------------------------------------------------------------------------- | -- |
| Item | Predicate - BD MAX™ Enteric Bacterial Panel (K140111) | Submitted Device - BD MAXTMEnteric Bacterial Panel withFecalSwab Collection,Preservation, and TransportSystem |
|---|---|---|
| Intended Use | The BD MAX™ Enteric Bacterial Panel performed on the BD MAX™ System is anautomated in vitro diagnostic test for the direct qualitative detection and differentiationof enteric bacterial pathogens. The BD MAX™ Enteric Bacterial Panel detects nucleicacids from:• Salmonella spp.• Campylobacter spp. (jejuni and coli)• Shigella spp. / Enteroinvasive E. coli (EIEC)• Shiga toxin 1 ( stxl ) / 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 stxl gene of STEC.Testing is performed on unpreserved soft to diarrheal stool specimens or Cary-Blairpreserved stool specimens from symptomatic patients with suspected acutegastroenteritis, enteritis or colitis. The test is performed directly on the specimen,utilizing real-time polymerase chain reaction (PCR) for the amplification of SpaO , aCampylobacter specific tuf gene sequence, ipaH and stx1/stx2 . The test utilizesfluorogenic sequence-specific hybridization probes for detection of the amplifiedDNA.This test is intended for use, in conjunction with clinical presentation, laboratoryfindings, and epidemiological information, as an aid in the differential diagnosis ofSalmonella, 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 thesole or definitive cause of patient illness. Negative results in the setting of clinicalillness compatible with gastroenteritis may be due to infection by pathogens that arenot detected by this test or non-infectious causes such as ulcerative colitis, irritablebowel syndrome, or Crohn's disease. | Same |
| Item | Predicate - BD MAX™ Enteric Bacterial Panel (K140111) | Submitted Device - BD MAX™Enteric Bacterial Panel withFecalSwab Collection,Preservation, and TransportSystem |
| Organisms Detected | • 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. | Same |
| Specimen Type | Unpreserved stool or Cary-Blair preserved stool | Same |
| Assay Format | Amplification: PCRDetection: Fluorogenic target-specific hybridization | Same |
| Mode of Detection | Presence of• tuf gene specific for Campylobacter• SpaO gene specific for Salmonella• ipaH gene specific for Shigella• stx1a and stx2a genes specific to Shiga-toxin producing organisms | Same |
| Interpretation of TestResults | Automated (BD MAX™ System diagnostic software) | Same |
| Analysis Platform | BD MAX™ System | Same |
| PCR SamplePreparation | Automated by the BD MAX™ System | Same |
| Detection Probes | TaqMan® Probe | Same |
| Assay Controls | Sample Processing Control (SPC) | Same |
| Cary-Blair BufferFormulation | -Sodium Chloride-Calcium Chloride-Phosphate Buffer-Thioglycolic Acid Sodium Salt-Phenol Red-Agar-Water | -Chloride salts-Sodium salts-Phosphate buffer-L-Cysteine-Agar-Water |
| Cary-Blair BufferContainer | Plastic Container w/Lid prefilled 15 ml of media | Plastic Container w/Lid prefilled2 ml of media |
| Item | Predicate - BD MAXTM Enteric Bacterial Panel (K140111) | Submitted Device - BD MAXTMEnteric Bacterial Panel withFecalSwab Collection,Preservation, and TransportSystem |
| Specimen TransferTool (unpreserved toCary-Blair) | Plastic Paddle | Flocked Swab |
| Transport Method toSBT Tube | 10 µL Transport Loop | 50 µL Pipette |
| Sterility ofFecalSwab | Not Applicable | Yes, Irradiation (FecalSwab) |
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| Item | Predicate - BD MAX Extended Enteric Bacterial Panel (K170308) | Proposed - BD MAX ExtendedEnteric Bacterial Panel withFecalSwab Collection,Preservation, and TransportSystem |
|---|---|---|
| Intended Use | The BD MAXTM Extended Enteric Bacterial Panel performed on the BD MAXTMSystem, is an automated in vitro diagnostic test for the direct qualitative detectionand differentiation of enteric bacterial pathogens. It is used in conjunction with theBD MAXTM Enteric Bacterial Panel as an optional Master Mix. The BD MAXTMExtended 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-stableenterotoxin (ST) genes• Yersinia enterocolitica | ||
| Testing is performed on unpreserved soft to diarrheal or Cary-Blair preserved stoolspecimens from symptomatic patients with suspected acute gastroenteritis, enteritisor colitis. The test is performed directly on the specimen, utilizing real-timepolymerase chain reaction (PCR) for the amplification of relevant gene target DNA.The test utilizes fluorogenic gene-specific hybridization probes for the detection ofthe amplified DNA. | Same | |
| This test is intended for use, in conjunction with clinical presentation, laboratoryfindings, and epidemiological information, as an aidin the differential diagnosis of Plesiomonas shigelloides, Vibrio (V. vulnificus, V.parahaemolyticus, and V. cholerae) Enterotoxigenic Escherichia coli (ETEC) LT/STand Yersinia enterocolitica infections. Results of this test should not be used as thesole basis for diagnosis, treatment, or other patient management decisions. Positiveresults do not rule out co-infection with other organisms that are not detected by thistest, and may not be the sole or definitive cause of patient illness. Negative results inthe setting of clinical illness compatible with gastroenteritis may be due to infection | ||
| Item | Predicate - BD MAX Extended Enteric Bacterial Panel (K170308) | Proposed - BD MAX ExtendedEnteric Bacterial Panel withFecalSwab Collection,Preservation, and TransportSystem |
| by pathogens that are not detected by this test or non-infectious causes such asulcerative colitis, irritable bowel syndrome, or Crohn's disease. | ||
| Organisms Detected | • Plesiomonas shigelloides• Vibrio ( V. vulnificus , V. parahaemolyticus , and V. cholerae )• Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT)/ heat-stableenterotoxin (ST) genes• Yersinia enterocolitica | Same |
| Specimen Type | Unpreserved stool or Cary-Blair preserved stool | Same |
| Assay Format | Amplification: PCRDetection: Fluorogenic target-specific hybridization | Same |
| Mode of Detection | Presence of• Undefined gene suspected to be implicated in Fe3+ transport for Plesiomonas shigelloides• atpA gene specific for Vibrio• eltA gene specific for Enterotoxigenic Escherichia coli• invA gene for Yersinia enterocolitica | Same |
| Interpretation of TestResults | Automated (BD MAXTM System diagnostic software) | Same |
| Analysis Platform | BD MAXTM System | Same |
| PCR SamplePreparation | Automated by the BD MAXTM System | Same |
| Detection Probes | TaqMan® Probe | Same |
| Assay Controls | Sample Processing Control (SPC) | Same |
| Cary-Blair BufferFormulation | Sodium ChlorideCalcium ChloridePhosphate BufferThioglycolic Acid Sodium SaltPhenol RedAgarWater | -Chloride salts-Sodium salts-Phosphate buffer-L-Cysteine-Agar-Water |
| Item | Predicate - BD MAX Extended Enteric Bacterial Panel (K170308) | Proposed - BD MAX ExtendedEnteric Bacterial Panel withFecalSwab Collection,Preservation, and TransportSystem |
| Cary-Blair BufferContainer | Plastic Container w/Lid prefilled 15 ml of media | Plastic Container w/Lid prefilled 2ml of media |
| Transfer Tool | Plastic Paddle | Nylon Flocked Swab |
| Transport Method toSBT Tube | Transport Loop | Pipette |
| Sterility ofFecalSwab | Not Applicable | Yes, Irradiation (FecalSwab) |
Table 2: Comparison of BD MAX™ Extended Enteric Bacterial Panel to Predicate Device
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Performance Evaluation
Four studies were conducted to demonstrate the substantial equivalence between the current predicate specimen collection (Cary-Blair) and the additional specimen collection (FecalSwab) for use in the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays:
- Confirmation of equivalent analytical sensitivity with the Copan FecalSwabTM . preserved stool specimen (FecalSwab) compared to the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel from a Cary-Blair Para-Pak® stool sample was performed by the limiting dilution LoD model. Acceptable performance was demonstrated when the detection break points between the FecalSwab and Cary-Blair Para-Pak® specimen types were within one five-fold dilution of each other. Break point is defined as the highest concentration where the positivity rate is <95% (<23/24). To achieve this comparison, a negative stool pool was prepared and divided into five aliquots, to which serially diluted multiplex organism mix was added. The organism mix contained a representative strain for each of the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel targets. The organism mixes contain one species from all claimed genera.
For the BD MAX™ Enteric Bacterial Panel the organism mix was prepared by combining the following targets in PBS: Salmonella typhimurium (ATCC 14028), Shigella sonnei (ATCC 9290), Campvlobacter jejuni (ATCC 43429), and Escherichia coli stx1 (ATCC 43890). For the BD MAX™ Extended Enteric Bacterial Panel the organism mix was prepared by combining the following targets in PBS: Plesiomonas shigelloides (ATCC 14029), V. parahaemolyticus (ATCC 178020), Y. enterocolitica (ATCC 9610), and Escherichia coli ETEC (ATCC 35401). The diluted BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel mixtures were spiked into aliquots of the stool pool. Three separate lots of FecalSwabs and one lot of scaled volume Cary-Blair were inoculated with each of the serially diluted stool samples. A 0.5 McFarland turbidity suspension was prepared for each organism. This suspension was diluted in PBS to create concentration 1 (Conc 1). Five additional concentrations (Conc 2-6) were prepared by performing 5-fold serial dilutions from Conc 1.
Limiting dilutions of specimens for each organism prepared using the FecalSwab™ and Para-Pak® exhibited drop-out rates at similar levels when tested with the BD MAX™ Enteric Bacterial Panel and the BD MAX™ Extended Enteric Bacterial Panel Assays on the BD MAXTM System. All FecalSwabTM break points were within one five-fold concentration when compared to Para-Pak® (Table 3). There was no indication that the FecalSwab™ collection device negatively impacted the analytical sensitivity of the BD MAX™ Enteric Bacterial Panel or BD MAX™ Extended Enteric Bacterial Panel.
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| Enteric Bacterial Panel | ||||||||
|---|---|---|---|---|---|---|---|---|
| Organism | S. typhimurium | E. coli stx1 | C. jejuni | S. sonnei | ||||
| Collection | FecalSwabTM | Para-Pak® | FecalSwabTM | Para-Pak® | FecalSwabTM | Para-Pak® | FecalSwabTM | Para-Pak® |
| Type | ||||||||
| Conc 1 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 |
| Conc 2 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 |
| Conc 3 | 22/24 | 16/24 | 24/24 | 23/24 | 24/24 | 24/24 | 24/24 | 23/24 |
| Conc 4 | 8/24 | 6/24 | 16/24 | 9/24 | 23/24 | 22/24 | 20/24 | 21/24 |
| Conc 5 | 3/24 | 7/24 | 3/24 | 6/24 | 14/24 | 13/24 | 13/24 | 15/24 |
| Conc 6 | 0/24 | 0/24 | 0/24 | 0/24 | 3/24 | 3/24 | 3/24 | 4/24 |
| Extended Enteric Bacterial Panel | ||||||||
| Organism | P. shigelloides | Y. enterocolitica | V. parahaemolyticus | E. coli ETEC | ||||
| Collection | FecalSwabTM | Para-Pak® | FecalSwabTM | Para-Pak® | FecalSwabTM | Para-Pak® | FecalSwabTM | Para-Pak® |
| Type | ||||||||
| Conc 1 | 24/24 | 23/23* | 24/24 | 23/23* | 24/24 | 23/23* | 24/24 | 23/23* |
| Conc 2 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 | 24/24 |
| Conc 3 | 24/24 | 17/24 | 24/24 | 17/24 | 24/24 | 18/24 | 24/24 | 18/24 |
| Conc 4 | 14/24 | 9/24 | 10/24 | 10/24 | 7/24 | 3/24 | 13/24 | 7/24 |
| Conc 5 | 3/24 | 6/24 | 2/24 | 1/24 | 1/24 | 0/24 | 6/24 | 4/24 |
| Conc 6 | 0/24 | 0/24 | 1/24 | 2/24 | 0/24 | 0/24 | 1/24 | 1/24 |
| Table 3: Number of Positive Samples for the BD MAXTM Enteric Bacterial Panel | |||||
|---|---|---|---|---|---|
*One non-reportable sample was not retested, and 23 replicates were accepted for the highest concentration.
- . Specimen Stability of stool specimen collected with the FecalSwab was tested against all target organisms. The results showed that specimen stability of FecalSwab meets the current BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assay stability claims. For each organism tested across both the BD MAX™ Enteric Bacterial Panel and BD MAXTM Extended Enteric Bacterial Panel assays, a detection ≥ 95% occurred at all the target stability time points claimed in the package insert. Therefore, stool preserved with FecalSwab can be stored for 24 hours (1 days) at 25 ± 2 °C and 120 hours (5 days) at 2 - 8 °C, and sample buffer tube inoculated with FecalSwab specimen can be stored for 48 hours (2 days) at 25 ± 2 °C and 120 hours (5 days) at 2 - 8 °C.
- A user variability study was performed using the FecalSwab since there are . differences in workflow (unpreserved sample to preservation media to SBT) between the FecalSwab and Cary-Blair Para-Pak® specimen collection. The data demonstrate that expected assay results are obtained when FecalSwab stool specimens were prepared by multiple users and shows that the difference in workflow between Cary-Blair Para-Pak® and FecalSwab specimen collection has no effect on the ability of the user to place the sample into the SBT for the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays.
The user variability study was performed to confirm that the preparation of the FecalSwab™ by different users does not induce variability in the expected results for the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays. Six (6) different users prepared two (2) different FecalSwab™ specimens from each of the five (5) panel members provided (one (1) negative panel member, three (3) low-positive panel members, and one (1)
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moderate-positive panel member;). Once the FecalSwab™ specimens were prepared by various users, all subsequent steps, including the transfer to SBTs from each FecalSwab™, were performed by a single experienced BD MAX™ user. Campylobacter jejuni was used for BD MAX™ Enteric Bacterial Panel assay because it is the most prevalent Enteric Bacterial Panel target and has the lowest LoD from Enteric Bacterial Panel targets. ETEC ST/LT was used for BD MAX™ Extended Enteric Bacterial Panel assay because it is the most prevalent Extended Enteric Bacterial target and has the second lowest LoD from Extended Enteric Bacterial targets.
Acceptance criteria were: 100% negative results for the twelve (12) negative samples, ≥95% positive results for the thirty-six (36) low-positive samples, and 100% positive for the twelve (12) moderate-positive samples. All conditions met acceptance criteria (Table 4)
| Target | Panel Member | AcceptanceCriteria | Assay Results | Results |
|---|---|---|---|---|
| Campylobacterjejuni andETEC | Moderate-Positive | 100% POS | 100% POS | |
| Campylobacterjejuni andETEC | Low-Positive | $\ge$ 95% POS | 100% POS | Pass |
| Negativesamples | Negative | 100% NEG | 100% NEG |
Table 4. Acceptance criteria for user variability
Results met all acceptance criteria. The data demonstrate that expected assay results are obtained when the FecalSwab™ fecal specimens were prepared by multiple users.
- The performance of the BD FecalSwab™ Collection, Transport and Preservation ● System when tested with the BD MAX™ Enteric Bacterial Panel and BD MAXTM Extended Enteric Bacterial Panel was evaluated in a comparison study by comparing the results obtained for specimens using Cary-Blair Para-Pak® preserved stool samples to those using the BD FecalSwab™ Collection, Transport and Preservation System. Both the BD FecalSwab™ and Copan FecalSwab™ are identical other than branding and were incorporated into the performance evaluation. Unpreserved stool samples were collected from pediatric and adult patients suspected of acute bacterial gastroenteritis, enteritis, or colitis from eight (8) geographically diverse clinical centers where specimens were collected as part of routine patient care. At these locations, the fresh, unpreserved stool samples were transferred into both Cary-Blair Para-Pak® collection vials and BD FecalSwab™ devices. All samples were subsequently shipped to a centralized testing laboratory and tested with the BD MAX™ Enteric Bacterial panel. A total
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of 621 prospective specimens and 295 retrospective specimens were enrolled in the clinical evaluation where three (3) prospective samples were excluded from the data analysis due to subject exclusion criteria. Table 5 describes the 913 (618 prospective and 295 retrospective) compliant specimens enrolled by patient age, sex, and specimen type. Sixteen (16) additional prospective samples were excluded from the data analysis due to specimen or instrument level exclusion criteria. The final data analysis included 897 compliant subjects for Campylobacter, Salmonella, Shigella spp. / Enteroinvasive E. coli (EIEC), Shiga toxin producing E. coli (STEC), Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus V. cholerae), Enterotoxigenic E. coli (ETEC) LT/ST, and Yersinia enterocolitica targets.
Table 5: Compliant Clinical Trial Enrollment Summary by Age, Sex, and Specimen Type
| Specimen Type | Mean Age inyears (SD) | Median Agein years | Min Agein years | Max Agein years | Sex of Total N |
|---|---|---|---|---|---|
| ProspectiveTotal N = 618Unknown Age: 0Known Age: 618 | 47.1 (22.4) | 49.0 | <1 | 95 | Male: 44.8%Female: 55.2%Unknown: 0.0% |
| RetrospectiveTotal N = 295Unknown Age: 149Known Age: 146 | 37.2 (20.8) | 33.5 | <1 | 86 | Male: 30.5%Female: 24.1%Unknown: 45.4% |
| OverallTotal N = 913Unknown Age: 149Known Age: 764 | 45.2 (22.4) | 47.0 | <1 | 95 | Male: 40.2%Female: 45.1%Unknown: 14.7% |
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAX™ Enteric Bacterial Panel identified 100.0% and 99.8% of the Campylobacter spp. prospective positive and negative specimens, respectively, and 100.0% and 97.1% of the retrospective positive and negative specimens, respectively (Table 6).
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| Campylobacter spp. | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 9 | 1 | 10 |
| Negative | 0 | 585 | 585 | |
| Total | 9 | 586 | 595 | |
| PPA: 100.0% (70.1%, 100.0%)NPA: 99.8% (99.0%, 100.0%) | ||||
| Positive | 88 | 6 | 94 | |
| Retrospective | Negative | 0 | 200 | 200 |
| Total | 88 | 206 | 294 | |
| PPA: 100.0% (95.8%, 100.0%) | ||||
| NPA: 97.1% (93.8%, 98.7%) |
| Table 6: Campylobacter spp. PPA and NPA of the BD MAXTM Enteric | |
|---|---|
| Bacterial Panel - FecalSwabTM Compared to Cary-Blair |
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAXTM Enteric Bacterial Panel identified 100.0% of the Salmonella spp. prospective positive and negative specimens, and 93.3% and 95.9% of the retrospective positive and negative specimens, respectively (Table 7).
Table 7: Salmonella spp. PPA and NPA of the BD MAX™ Enteric Bacterial Panel - FecalSwab™ Compared to Cary-Blair
| Salmonella spp. | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 4 | 0 | 4 |
| Negative | 0 | 591 | 591 | |
| Total | 4 | 591 | 595 | |
| PPA: 100.0% (51.0%, 100.0%)NPA: 100.0% (99.4%, 100.0%) | ||||
| Retrospective | Positive | 70 | 9 | 79 |
| Negative | 5 | 210 | 215 | |
| Total | 75 | 219 | 294 | |
| PPA: 93.3% (85.3%, 97.1%)NPA: 95.9% (92.4%, 97.8%) |
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAXTM Enteric Bacterial Panel identified 100% of the Shigella spp. prospective positive and negative specimens, and 98.1% and 99.6% of the retrospective positive and negative specimens, respectively (Table 8).
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| Shigella spp. | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 7 | 0 | 7 |
| Negative | 0 | 588 | 588 | |
| Total | 7 | 588 | 595 | |
| PPA: 100.0% (64.6%, 100.0%) | ||||
| NPA: 100.0% (99.4%, 100.0%) | ||||
| Retrospective | Positive | 52 | 1 | 53 |
| Negative | 1 | 240 | 241 | |
| Total | 53 | 241 | 294 | |
| PPA: 98.1% (90.1%, 99.7%) | ||||
| NPA: 99.6% (97.7%, 99.9%) |
Table 8: Shigella spp. PPA and NPA of the BD MAX™ Enteric Bacterial Panel - FecalSwab™ Compared to Carv-Blair
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAX™ Enteric Bacterial Panel identified 100.0% and 99.5% of the stx1/stx2 (STX) prospective positive and negative specimens, respectively, and 92.9% and 100.0% of the retrospective positive and negative specimens, respectively (Table 9.
Table 9: stx1/stx2 (STX) PPA and NPA of the BD MAX™ Enteric Bacterial Panel - FecalSwab™ Compared to Cary-Blair
| STX | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 1 | 3 | 4 |
| Negative | 0 | 591 | 591 | |
| Total | 1 | 594 | 595 | |
| PPA: 100.0% (20.7%, 100.0%)NPA: 99.5% (98.5%, 99.8%) | ||||
| Retrospective | Positive | 13 | 0 | 13 |
| Negative | 1 | 281 | 282 | |
| Total | 14 | 281 | 295 | |
| PPA: 92.9% (68.5%, 98.7%)NPA: 100.0% (98.7%, 100.0%) |
In addition, due to the small number of stx1/stx2 (STX) positive specimens in the study, contrived specimens were evaluated. The BD FecalSwabTM Collection, Transport and Preservation System on the BD MAX™ Enteric Bacterial Panel identified 100% of the stx1/stx2 (STX) contrived positive and negative specimens, when compared to expected results (Table 10).
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| STX | Expected Results | |||
|---|---|---|---|---|
| Contrived | Positive | 53 | 0 | 53 |
| Negative | 0 | 53 | 53 | |
| Total | 53 | 53 | 106 | |
| PPA: 100.0% (93.2%, 100.0%) | ||||
| NPA: 100.0% (93.2%, 100.0%) |
Table 10: STX Contrived FecalSwab™ Specimen Results
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAXTM Enteric Bacterial Panel identified 100.0% and 99.0% of the Plesiomonas shigelloides prospective positive and negative specimens, respectively, and 33.3% and 100.0% of the retrospective positive and negative specimens, respectively (Table 11).
Table 11: Plesiomonas shigelloides PPA and NPA of the BD MAX™ Extended Enteric Bacterial Panel - FecalSwab™ Compared to Cary-Blair
| Plesiomonas shigelloides | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 2 | 6 | 8 |
| Negative | 0 | 586 | 586 | |
| Total | 2 | 592 | 594 | |
| PPA: 100.0% (34.2%, 100.0%) | ||||
| NPA: 99.0% (97.8%, 99.5%) | ||||
| Retrospective | Positive | 1 | 0 | 1 |
| Negative | 2 | 291 | 293 | |
| Total | 3 | 291 | 294 | |
| PPA: 33.3% (6.1%, 79.2%) | ||||
| NPA: 100.0% (98.7%, 100.0%) |
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAXTM Enteric Bacterial Panel identified 99.7% of the Vibrio spp. prospective negative specimens (zero prospective positives specimens were analyzed), and 100.0% of the retrospective positive and negative specimens (Table 12).
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Table 12: Vibrio spp. PPA and NPA of the BD MAX™ Extended Enteric Bacterial Panel - FecalSwab™ Compared to Cary-Blair
| Vibrio | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 0 | 2 | 2 |
| Negative | 0 | 592 | 592 | |
| Total | 0 | 594 | 594 | |
| PPA: Not AvailableNPA: 99.7% (98.8%, 99.9%) | ||||
| Retrospective | Positive | 4 | 0 | 4 |
| Negative | 0 | 290 | 290 | |
| Total | 4 | 290 | 294 | |
| PPA: 100.0% (51.0%, 100.0%)NPA: 100.0% (98.7%, 100.0%) |
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAX™ Enteric Bacterial Panel identified 100.0% of the ETEC prospective positive and negative specimens, and 100.0% and 99.6%-of the retrospective positive and negative specimens, respectively (Table 13).
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| ETEC | Cary-Blair | |||
|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total |
| Prospective | Positive | 2 | 0 | 2 |
| Negative | 0 | 592 | 592 | |
| Total | 2 | 592 | 594 | |
| PPA: 100.0% (34.2%, 100.0%)NPA: 100.0% (99.4%, 100.0%) | ||||
| Retrospective | Positive | 14 | 1 | 15 |
| Negative | 0 | 279 | 279 | |
| Total | 14 | 280 | 294 | |
| PPA: 100.0% (78.5%, 100.0%) | ||||
| NPA: 99.6% (98.0%, 99.9%) |
Table 13: ETEC PPA and NPA of the BD MAX™ Extended Enteric Bacterial Panel - FecalSwab™ Compared to Cary-Blair
For the BD FecalSwab™ Collection, Transport and Preservation System, the BD MAX™ Enteric Bacterial Panel identified 100.0% of the Yersinia enterocolitica prospective negative specimens (zero prospective positive specimens were analyzed), and 100.0% and 99.0% of the retrospective positive and negative specimens, respectively (Table 14).
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| Yersinia enterocolitica | Cary-Blair | ||||
|---|---|---|---|---|---|
| Specimen Origin | FecalSwab | Positive | Negative | Total | |
| Prospective | Positive | 0 | 0 | 0 | |
| Negative | 1 | રુત્વે રેતે રેતા પ્રતિષ્ઠા જિલ્લામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે મુખ્યત્વે આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે આવે | રુવે | ||
| Total | 1 | રુજરાત રાજ્યના મધ્યમાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે પ્રતિષ્ઠા તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં લોકોનો મુખ્ય વ્ | 594 | ||
| NPA: 100.0% (99.4%, 100.0%) | |||||
| Retrospective | Positive | 4 | 3 | 7 | |
| Negative | 0 | 287 | 287 | ||
| Total | 4 | 290 | 294 | ||
| PPA: 100.0% (51.0%, 100.0%) | |||||
| NPA: 99.0% (97.0%, 99.6%) |
Table 14: Yersinia enterocolitica PPA and NPA of the BD MAX™ Extended Enteric Bacterial Panel - FecalSwab™ Compared to Cary-Blair
Additional contrived specimens were evaluated due to low prevalence of the targets in the study. The BD FecalSwab™ Collection, Transport and Preservation System on the BD MAX™ Extended Enteric Bacterial Panel identified 100.0% of the Plesiomonas shigelloides contrived positive and negative specimens, when compared to expected results (Table 15).
Table 15: Plesiomonas shigelloides Contrived FecalSwab™ Specimen Results
| Plesiomonasshigelloides | Expected Results | |||
|---|---|---|---|---|
| Contrived | Positive | 53 | 0 | 53 |
| Negative | 0 | 53 | 53 | |
| Total | 53 | 53 | 106 | |
| PPA: 100.0% (93.2%, 100.0%) | ||||
| NPA: 100.0% (93.2%, 100.0%) |
{25}------------------------------------------------
The BD FecalSwab™ Collection, Transport and Preservation System on the BD MAX™ Extended Enteric Bacterial Panel identified 98.1% and 100.0% of the positive and negative Vibrio contrived positive and negative specimens, respectively, when compared to expected results (Table 16).
Table 16: Vibrio Contrived FecalSwab™ Specimen Results
| Vibrio ssp. | Expected Results | |||
|---|---|---|---|---|
| Contrived | Positive | 52 | 0 | 52 |
| Negative | 1 | 53 | 54 | |
| Total | 53 | 53 | 106 | |
| PPA: 98.1% (90.1%, 99.7%)NPA: 100.0% (93.2%, 100.0%) |
The BD FecalSwab™ Collection, Transport and Preservation System on the BD MAX™ Extended Enteric Bacterial Panel identified 100.0% of the ETEC contrived positive and negative specimens, when compared to expected results (Table 17).
Table 17: ETEC Contrived FecalSwab™ Specimen Results
| ETEC | Expected Results | |||
|---|---|---|---|---|
| Contrived | Positive | 53 | 0 | 53 |
| Negative | 0 | 53 | 53 | |
| Total | 53 | 53 | 106 | |
| PPA: 100.0% (93.2%, 100.0%) | ||||
| NPA: 100.0% (93.2%, 100.0%) |
The BD FecalSwab™ Collection, Transport and Preservation System on the BD MAX™ Extended Enteric Bacterial Panel identified 98.1% and 100.0% of the positive and negative Yersinia enterocolitica contrived positive and negative specimens, respectively, when compared to expected results (Table 18).
Table 18: Yersinia enterocolitica Contrived FecalSwab™ Specimen Results
| Yersiniaenterocolitica | Expected Results | |||
|---|---|---|---|---|
| Contrived | Positive | 52 | 0 | 52 |
| Negative | 1 | 53 | 54 | |
| Total | 53 | 53 | 106 | |
| PPA: 98.1% (90.1%, 99.7%) | ||||
| NPA: 100.0% (93.2%, 100.0%) |
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).