BD MAX Enteric Viral Panel, BD MAX Instrument

K181427 · Becton, Dickinson and Company · PCH · Nov 29, 2018 · Microbiology

Device Facts

• Record ID: K181427
• Device Name: BD MAX Enteric Viral Panel, BD MAX Instrument
• Applicant: Becton, Dickinson and Company
• Product Code: PCH · Microbiology
• Decision Date: Nov 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3990
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAX™ Enteric Viral Panel detects nucleic acids from Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Human Astrovirus (hAstro). Testing is performed on unpreserved soft to diarrheal 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 relevant gene target DNA/RNA. 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 Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Astrovirus 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 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.

Device Story

The BD MAX Enteric Viral Panel is an automated in vitro diagnostic test performed on the BD MAX System. It processes unpreserved or Cary-Blair preserved stool specimens from symptomatic patients. The system automates sample preparation, including target lysis, DNA/RNA extraction, and concentration. It utilizes real-time PCR for amplification and fluorogenic gene-specific hybridization probes for detection. The system interprets results automatically as Positive, Negative, or Unresolved. It is used in clinical laboratories to aid in the differential diagnosis of enteric viral infections. Healthcare providers use the results in conjunction with clinical and epidemiological data to guide patient management. The device benefits patients by providing rapid, automated identification of viral pathogens, facilitating appropriate clinical decision-making.

Clinical Evidence

Multi-site clinical study of 2,148 compliant specimens (1,146 Cary-Blair, 1,002 unpreserved). Compared against a reference method of alternate PCRs and bi-directional sequencing. Prospective and retrospective samples evaluated. PPA/NPA results: Norovirus (PPA 90.7-100%, NPA 99.1-100%), Rotavirus (PPA 100%, NPA 97.9-99.9%), Adenovirus (PPA 80-100%, NPA 99.9-100%), Sapovirus (PPA 66.7-100%, NPA 97.5-100%), and Astrovirus (PPA 90.9-100%, NPA 97.8-99.9%).

Technological Characteristics

Automated bench-top molecular diagnostics workstation. Uses microfluidic cartridges, master mixes, and unitized reagent strips. Sensing principle: real-time PCR with fluorogenic TaqMan hydrolysis probes. Energy source: electrical (BD MAX System). Connectivity: standalone instrument. Software: automated interpretation of amplification curves and SPC. Sterilization: not specified.

Indications for Use

Indicated for symptomatic patients (all ages) with suspected acute gastroenteritis or colitis. Used for qualitative detection and differentiation of Norovirus GI/GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Human Astrovirus from unpreserved or Cary-Blair preserved 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

• BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel (K143005)

Submission Summary (Full Text)

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November 29, 2018

Becton, Dickinson and Company Laura Stewart Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152

Re: K181427

Trade/Device Name: BD MAX Enteric Viral Panel, BD MAX Instrument Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal microorganism multiplex nucleic acid-based assay Regulatory Class: Class II Product Code: PCH, OOI Dated: May 30, 2018 Received: June 1, 2018

Dear Laura Stewart:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

#### Steven R. Gitterman -S for

Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181427

Device Name BD MAX™ Enteric Viral Panel

#### Indications for Use (Describe)

The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAX™ Enteric Viral Panel detects nucleic acids from

- . Norovirus GI & GII
- . Rotavirus A
- . Adenovirus F40/41
- . Sapovirus (genogroups I, II, IV, V)
- . Human Astrovirus (hAstro)

Testing is performed on unpreserved soft to diarrheal 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 relevant gene target DNA/RNA. 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 Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Astrovirus 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 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) |
|----------------------------------------------------|
| \[X\] 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 Viral Panel

# Summary Preparation Date:

# 5/30/2018

# Submitted by:

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152

# Contact:

Laura Stewart Staff Regulatory Affairs Specialist

Tel: [phone] Fax: [phone] Email: [e-mail]

# Proprietary Names:

For the instrument: BD MAX™ System For the assay: BD MAX™ Enteric Viral Panel (EVP)

# Common Names:

For the instrument: Bench-top molecular diagnostics workstation For the assay: Gastrointestinal viral panel multiplex nucleic acid-based assay system Enteric viral panel Enteric viral nucleic acid test Enteric viral identification and differentiation system Enteric assay Enteric test

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# Regulatory Information

Regulation section: 866.3990 - Gastrointestinal microorganism multiplex nucleic acid-based assay.

Classification: Class II

Panel: Microbiology (83)

Product Code(s): PCH - Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System OOI - Real Time Nucleic Acid Amplification System

# Predicate Device

BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel [510(k) K143005]

# Device Establishment

Becton, Dickinson and Company BD Diagnostic Systems 7 Loveton Circle Sparks, Maryland 21152 USA

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

The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAXTM Enteric Viral Panel detects nucleic acids from

- Norovirus GI & GII ●
- Rotavirus A
- Adenovirus F40/41 .
- . Sapovirus (genogroups I, II, IV, V)
- . Human Astrovirus (hAstro)

Testing is performed on unpreserved soft to diarrheal 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 relevant gene target DNA/RNA. The test utilizes fluorogenic gene-specific 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 Norovirus GI & GII, Rotavirus A. Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Astrovirus 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.

# Special Conditions for Use Statement: For prescription use.

# Special Instrument Requirements: BD MAX™ System

# Device Description

The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAXTM Enteric Viral Panel detects nucleic acids from

- Norovirus GI & GII
- Rotavirus A
- Adenovirus F40/41
- Sapovirus (genogroups I, II, IV, V) .
- . Human Astrovirus (hAstro)

Testing is performed on unpreserved soft to diarrheal 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 relevant gene target DNA/RNA. The test utilizes fluorogenic gene-specific hybridization probes for the detection of the amplified DNA.

The BD MAX™ System and the BD MAX™ Enteric Viral Panel is run with the instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA/RNA extraction and concentration, reagent rehydration, and 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/RNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test result may be called as POS (Positive), NEG (Negative), or UNR (Unresolved) for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAXTM System failure.

# Test Principle

Stool specimens are collected from subjects and transported to the laboratory unpreserved in a clean container or preserved in Cary-Blair transport media. A loop is inserted to the depth of the loop into the specimen and expressed via swirling motion into a BD MAX™ Sample Buffer Tube included in the BD MAX™ Enteric Viral Panel kit. The Sample Buffer Tube is closed with a septum cap, vortexed and transferred to the BD MAX™ System. Once the work list is generated and the specimen is loaded on the BD MAX™ instrument, along with a BD MAXIM Enteric Viral Panel Unitized Reagent Strip and PCR Cartridge, the run is started and no further operator intervention is required. The BD MAX™ System

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automates specimen preparation. including target organism lysis. DNA/RNA extraction and concentration, reagent rehydration, target nucleic acid sequence amplification and detection using realtime PCR. The interpretation of the signal is performed automatically by the BD MAX™ System. The assay also includes a Sample Processing Control that is provided in the Extraction Tube and subjected to extraction, concentration and amplification steps. The Sample Processing Control monitors for the presence of potential inhibitory substances as well as system or reagent failures. Following enzymatic viral lysis at elevated temperature, the released nucleic acids are captured by magnetic affinity beads.

The beads, with the bound nucleic acids, are washed and the nucleic acids are eluted. Eluted DNA/RNA is neutralized and transferred to the Master Mix tubes to rehydrate the PCR reagents. After rehydration, the BD MAX™ System dispenses a fixed volume of PCR-ready solution into the BD MAX™ PCR Cartridge. Microvalves in the BD MAX™ PCR Cartridge are sealed by the system to prevent evaporation and amplicon contamination prior to the initiation of reverse transcriptase PCR to convert RNA to cDNA and subsequent real time PCR.

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 amplicons of the viral targets (Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and hAstro) and the Sample Processing Control amplicons in four 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 cDNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD MAX™ System monitors these signals at each cycle, and interprets the data at the end of the program to report the final results.

#### Substantial Equivalence2

Table 1 shows the similarities and Table 2 shows the differences between the BD MAXTM Enteric Viral Panel and the predicate device.

The term "substantial equivalence" as used in this 510(k) 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, Subpart 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 infingement 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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| | Similarities | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | BD MAX™ Enteric Viral Panel (EVP) | FilmArray GI Panel (K143005) |
| Intended Use | The BD MAX™ Enteric Viral Panel performed on<br>the BD MAX System, is an automated <i>in vitro</i><br>diagnostic test for the direct qualitative detection and<br>differentiation of enteric viral pathogens. The BD<br>MAX™ Enteric Viral Panel detects nucleic acids<br>from<br>• Norovirus GI & GII<br>• Rotavirus A<br>• Adenovirus F40/41<br>• Sapovirus (genogroups I, II, IV, V)<br>• Human Astrovirus (hAstro)<br><br>Testing is performed on unpreserved soft to diarrheal<br>or Cary-Blair preserved stool specimens from<br>symptomatic patients with suspected acute<br>gastroenteritis, enteritis or colitis. The test is<br>performed directly on the specimen, utilizing real-<br>time polymerase chain reaction (PCR) for the<br>amplification of relevant gene target DNA/RNA.<br>The test utilizes fluorogenic gene-specific<br>hybridization probes for the detection of the<br>amplified DNA.<br><br>This test is intended for use, in conjunction with<br>clinical presentation, laboratory findings, and<br>epidemiological information, as an aid in the<br>differential diagnosis of Norovirus GI & GII,<br>Rotavirus A, Adenovirus F40/41, Sapovirus<br>(genogroups I, II, IV, V), and Astrovirus infections.<br>Results of this test should not be used as the sole<br>basis for diagnosis, treatment, or other patient<br>management decisions. Positive results do not rule<br>out co-infection with other organisms that are not<br>detected by this test, and may not be the sole or<br>definitive cause of patient illness. Negative results in<br>the setting of clinical illness compatible with<br>gastroenteritis may be due to infection by pathogens<br>that are not detected by this test or non-infectious<br>causes such as ulcerative colitis, irritable bowel<br>syndrome, or Crohn's disease. | The FilmArray Gastrointestinal (GI) Panel is a<br>qualitative multiplexed nucleic acid-based <i>in vitro</i><br>diagnostic test intended for use with FilmArray<br>systems. The FilmArray GI Panel is capable of the<br>simultaneous detection and identification of nucleic<br>acids from multiple bacteria, viruses, and parasites<br>directly from stool samples in Cary Blair transport<br>media obtained from individuals with signs and/or<br>symptoms of gastrointestinal infection. The<br>following bacteria (including several diarrheagenic<br><i>E. coli/Shigella</i> pathotypes), parasites, and viruses<br>are identified using the FilmArray GI Panel:<br>• <i>Campylobacter (C. jejuni/C. coli/C. upsaliensis)</i><br>• <i>Clostridium difficile (C. difficile)</i> toxin A/B<br>• <i>Plesiomonas shigelloides</i><br>• <i>Salmonella</i><br>• <i>Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae)</i> , including specific identification of<br><i>Vibrio cholerae</i><br>• <i>Yersinia enterocolitica</i><br>• <i>Enteroaggregative Escherichia coli (EAEC)</i><br>• <i>Enteropathogenic Escherichia coli (EPEC)</i><br>• <i>Enterotoxigenic Escherichia coli (ETEC) lt/st</i><br>• <i>Shiga-like toxin-producing Escherichia coli<br/>(STEC) stx1/stx2</i> (including specific<br>identification of the <i>E. coli</i> O157 serogroup<br>within STEC)<br>• <i>Shigella/Enteroinvasive Escherichia coli (EIEC)</i><br>• <i>Cryptosporidium</i><br>• <i>Cyclospora cayetanensis</i><br>• <i>Entamoeba histolytica</i><br>• <i>Giardia lamblia</i> (also known as <i>G. intestinalis<br/>and G. duodenalis</i> )<br>• Adenovirus F 40/41<br>• Astrovirus<br>• Norovirus GI/GII<br>• Rotavirus A<br>• Sapovirus (Genogroups I, II, IV, and V)<br><br>The FilmArray GI Panel is indicated as an aid in the<br>diagnosis of specific agents of gastrointestinal<br>illness and results are meant to be used in<br>conjunction with other clinical, laboratory, and<br>epidemiological data. Positive results do not rule out<br>co-infection with organisms not included in the<br>FilmArray GI Panel. The agent detected may not be<br>the definite cause of the disease.<br><br>Concomitant culture is necessary for organism<br>recovery and further typing of bacterial agents.<br>This device is not intended to monitor or guide<br>treatment for <i>C. difficile</i> infection.<br><br>Due to the small number of positive specimens<br>collected for certain organisms during the<br>prospective clinical study, performance<br>characteristics for <i>E. coli</i> O157, <i>Plesiomonas</i><br><i>shigelloides, Yersinia enterocolitica, Astrovirus</i> , and |
| Similarities | | |
| Item | BD MAX™ Enteric Viral Panel (EVP) | FilmArray GI Panel (K143005) |
| | | Rotavirus A were established primarily with retrospective clinical specimens.<br>Performance characteristics for Entamoeba histolytica, and Vibrio (V. parahaemolyticus, V. vulnificus, and Vibrio cholerae) were established primarily using contrived clinical specimens.<br>Negative FilmArray GI Panel 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.<br>A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. |
| Specimen<br>Type | Cary-Blair preserved stool<br>Unpreserved soft to diarrheal stool | Cary-Blair preserved stool.<br>Not claimed (see Differences below) |
| Assay Format | Amplification: PCR<br>Detection: fluorogenic target-specific hybridization. | Amplification: PCR<br>Detection: non target-specific fluorescent dye |
| Organisms<br>Detected | • Norovirus GI & GII<br>• Rotavirus A<br>• Adenovirus F40/41<br>• Sapovirus (genogroups I, II, IV, V)<br>• Human Astrovirus (hAstro) | • Norovirus GI/GII<br>• Rotavirus A<br>• Adenovirus F 40/41<br>• Sapovirus (Genogroups I, II, IV, V)<br>• Astrovirus |
| Interpretation<br>of Test<br>Results | Automated: BD MAX™ System diagnostic software | Automated |
| Analysis<br>Platform | BD MAXTM System | Film Array Instrument |
| PCR Sample<br>preparation | Automated:<br>BD MAX™ System | Automated:<br>Film Array Instrument |
| Detection<br>Probes | TaqMan® Probe | Fluorescent double stranded DNA binding dye (LC<br>Green Plus) |
| Assay<br>Controls | Sample Processing Control (SPC)…