(203 days)
Not Found
No
The description mentions "BD MAX™ System software automatically interprets test results" based on "amplification status of the targets and of the Sample Processing Control." This indicates a rule-based or algorithmic interpretation, not AI/ML. There is no mention of AI, ML, or related concepts like training data or complex pattern recognition beyond simple thresholding of amplification signals.
No
This device is an in vitro diagnostic (IVD) test used to detect and differentiate viral pathogens from stool specimens. It provides information to aid in diagnosis but does not directly treat or manage a patient's condition, which are functions of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is an "automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens." It also mentions "This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis."
No
The device description explicitly states that the BD MAX™ Enteric Viral Panel assay 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, in addition to the software. This indicates it is a system with significant hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / 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)
- . 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 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.
Product codes
PCH, OOI
Device Description
The BD MAX™ Enteric Viral Panel assay 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, nucleic acid 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 nucleic acid 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 MAX™ Enteric Viral 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The clinical evaluation included pediatric and adult patients. Ranges observed were 95% occurred at all target stability time points claimed. Stool preserved with FecalSwab can be stored for up to 120 hours (5 days) at 2 - 8 °C or for up to 48 hours at 2 - 25 °C. Sample buffer tube inoculated with FecalSwab specimen can be stored at 2 - 8 °C for a maximum of 120 hours (5 days) or at 2 - 25 ℃ for a maximum 48 hours (2 days).
-
User Variability Study:
- Study Type: User variability study.
- Sample Size: Six (6) different users prepared two (2) different FecalSwab™ specimens from each of the five (5) panel members (one negative, three low-positive, one moderate-positive). This equates to 60 samples (6 users * 2 specimens * 5 panel members).
- Key Results: All conditions met acceptance criteria: 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. 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 user's ability to place sample into the SBT.
-
Multicenter Clinical Study:
- Study Type: Multicenter clinical evaluation comparing FecalSwab™ Collection, Transport and Preservation System to Cary-Blair Para-Pak® preserved stool samples.
- Sample Size: 581 compliant prospective and 211 compliant retrospective subjects.
- Key Results (PPA and NPA compared to Cary-Blair Preserved):
- Norovirus (Prospective): PPA: 87.0% (67.9%, 95.5%), NPA: 99.6% (98.7%, 99.9%)
- Norovirus (Retrospective): PPA: 99.0% (94.8%, 99.8%), NPA: 94.3% (88.2%, 97.4%)
- Rotavirus (Prospective): PPA: 100.0% (43.9%, 100.0%), NPA: 100.0% (99.3%, 100.0%)
- Rotavirus (Retrospective): PPA: 84.8% (71.8%, 92.4%), NPA: 98.2% (94.8%, 99.4%)
- Adenovirus (Prospective): PPA: 100.0% (20.7%, 100.0%), NPA: 99.5% (98.5%, 99.8%)
- Adenovirus (Retrospective): PPA: 100.0% (70.1%, 100.0%), NPA: 99.0% (96.5%, 99.7%)
- Adenovirus (Contrived): PPA: 100.0% (93.1%, 100.0%), NPA: 100.0% (93.2%, 100.0%) (N=105)
- Sapovirus (Prospective): PPA: 50.0% (9.5%, 90.5%), NPA: 99.3% (98.2%, 99.7%)
- Sapovirus (Retrospective): PPA: 100.0% (85.1%, 100.0%), NPA: 97.9% (94.7%, 99.2%)
- Astrovirus (Prospective): PPA: 100.0% (20.7%, 100.0%), NPA: 99.3% (98.2%, 99.7%)
- Astrovirus (Retrospective): PPA: 96.3% (81.7%, 99.3%), NPA: 96.7% (93.1%, 98.5%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics in the clinical study were Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
- Norovirus (Prospective): PPA: 87.0% (67.9%, 95.5%), NPA: 99.6% (98.7%, 99.9%)
- Norovirus (Retrospective): PPA: 99.0% (94.8%, 99.8%), NPA: 94.3% (88.2%, 97.4%)
- Rotavirus (Prospective): PPA: 100.0% (43.9%, 100.0%), NPA: 100.0% (99.3%, 100.0%)
- Rotavirus (Retrospective): PPA: 84.8% (71.8%, 92.4%), NPA: 98.2% (94.8%, 99.4%)
- Adenovirus (Prospective): PPA: 100.0% (20.7%, 100.0%), NPA: 99.5% (98.5%, 99.8%)
- Adenovirus (Retrospective): PPA: 100.0% (70.1%, 100.0%), NPA: 99.0% (96.5%, 99.7%)
- Adenovirus (Contrived): PPA: 100.0% (93.1%, 100.0%), NPA: 100.0% (93.2%, 100.0%)
- Sapovirus (Prospective): PPA: 50.0% (9.5%, 90.5%), NPA: 99.3% (98.2%, 99.7%)
- Sapovirus (Retrospective): PPA: 100.0% (85.1%, 100.0%), NPA: 97.9% (94.7%, 99.2%)
- Astrovirus (Prospective): PPA: 100.0% (20.7%, 100.0%), NPA: 99.3% (98.2%, 99.7%)
- Astrovirus (Retrospective): PPA: 96.3% (81.7%, 99.3%), NPA: 96.7% (93.1%, 98.5%)
Predicate Device(s):
BD MAX™ Enteric Viral Panel (K181427)
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2022
Becton, Dickinson and Company Joseph Basore Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152
Re: K220607
Trade/Device Name: BD MAX Enteric Viral Panel Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay Regulatory Class: Class II Product Code: PCH, OOI Dated: March 1, 2022 Received: March 2, 2022
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
1
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 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 medical devices and radiation-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,
for
Noel Gerald Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220607
Device Name BD MAXTM 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 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:
03/01/2022
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 Viral Panel
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: 21 CFR 866.3990 - Gastrointestinal microorganism multiplex nucleic acid-based assay
Classification: Class II (Special Controls)
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 BD MAX™ Enteric Viral Panel (K181427)
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
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, 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/RNA. The test utilizes fluorogenic gene-specific hybridization probes for detection of the amplified DNA.
5
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 hAstro 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 Only
Special Instrument Requirements: BD MAX™ Enteric Viral Panel is performed on the BD MAX™ System
Device Description
The BD MAX™ Enteric Viral Panel assay 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, nucleic acid 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 nucleic acid 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 MAX™ Enteric Viral 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 Viral Panel assay is designed for use with unpreserved or Cary-Blair preserved stool samples. Unpreserved samples are placed in a BD MAX sample buffer tube (SBT) using the provided 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 the provided transfer loop prior to analysis on the BD MAX™ System.
To use the FecalSwabTM 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. Last, before analysis on the BD MAX™ System, samples collected/stored with the FecalSwab™ system are vortexed and then pipetted (25 ul) into a BD MAXTM SBT.
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Once specimens (Unpreserved, Cary-Blair, or FecalSwab Cary-Blair) are placed into a BD MAX™ SBT, the test principles are as described in K181427. For all specimen types the SBTs are vortexed and then loaded into the BD MAX™ System along with the Unitized Reagent Strips, Master Mixes, Extraction Tubes, and PCR Cartridges. No further operator intervention is necessary, and the following automated procedures occur. The target viruses are lysed, and nucleic acid 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/RNA 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/RNA 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 Astrovirus) 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. The assay includes a Sample Processing Control, which monitors the integrity of the reagents as well as the process steps involved in DNA/RNA extraction, amplification and detection, and checks for the presence of potential assay inhibitors.
Substantial Equivalence1
Table 1 provides the similarities and differences between the submitted device and the legally marketed predicate device.
1 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. A determination of substantial equivalency under this 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 aganst interest under the US Patent Laws or the courts.
7
| Item | Predicate - BD MAX Enteric Viral Panel (K181427) | Proposed - BD MAX Enteric Viral Panel with Copan FecalSwab Collection, Preservation, and Transport System |
|---|---|---|
| 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 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, 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/RNA. The test utilizes fluorogenic gene-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 Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V) and hAstro 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. | Same | |
| Organisms Detected | Norovirus GI & GII Rotavirus A Adenovirus F40/41 Sapovirus (genogroups I, II, IV, V) Human Astrovirus (hAstro) | Same |
| Specimen Type | Unpreserved stool or Cary-Blair preserved stool | Same |
| Item | Predicate - BD MAX Enteric Viral Panel (K181427) | Proposed - BD MAX Enteric Viral Panel with Copan FecalSwab Collection, Preservation, and Transport System |
| Assay Format | Amplification: PCR | |
| Detection: Fluorogenic target-specific hybridization | Same | |
| Mode of Detection | Presence of | |
| • RdRp and VPI genes specific for Norovirus GI & GII | ||
| • non-coding sequence after nsp-3 gene specific for Rotavirus A | ||
| • hexon gene specific for Adenovirus F40/41 | ||
| • RdRp and VP1 genes specific to Sapovirus (genogroups I, II, IV, V) | ||
| • RdRp gene specific to Human Astrovirus (hAstro) | Same | |
| Interpretation of Test Results | Automated (BD MAX™ System diagnostic software) | Same |
| Analysis Platform | BD MAX™ System | Same |
| PCR Sample Preparation | Automated by the BD MAX™ System | Same |
| Detection Probes | TaqMan® Probe | Same |
| Assay Controls | Sample Processing Control (SPC) | Same |
| Preservation Buffer Formulation | • Cary-Blair: | |
| Sodium Chloride | ||
| Calcium Chloride | ||
| Phosphate Buffer | ||
| Thioglycolic Acid Sodium Salt | ||
| Phenol Red | ||
| Agar | ||
| Water | ||
| • Unpreserved: Not Applicable | • Cary-Blair: Same | |
| • Unpreserved: Same | ||
| • FecalSwab: | ||
| Sodium Chloride | ||
| Calcium Chloride | ||
| Phosphate Buffer | ||
| L-Cysteine | ||
| Agar | ||
| Water | ||
| Preservation Buffer Container | • Cary-Blair: Plastic Container w/Lid prefilled 15 ml of media. | |
| • Unpreserved: Not Applicable | • Cary-Blair: Same | |
| • Unpreserved: Same | ||
| • FecalSwab: Plastic Container w/Lid prefilled 2 ml of media | ||
| Transfer Tool to Preservation Buffer | • Cary-Blair: Plastic Paddle | |
| • Unpreserved: Not Applicable | • Cary-Blair: Same | |
| • Unpreserved: Same | ||
| • FecalSwab: Flocked Swab | ||
| Transport Method to SBT Tube | • Cary-Blair: 5 µL Transport Loop | |
| • Unpreserved: 5 µL Transport Loop | • Cary-Blair: Same | |
| • Unpreserved: Same | ||
| • FecalSwab: 25 µL Pipette | ||
| Sterile | • Cary-Blair: Not Applicable | |
| • Unpreserved: Not Applicable | • Cary-Blair: Same | |
| • Unpreserved: Same | ||
| • FecalSwab: Yes, Irradiation |
Table 1: Comparison of EVP 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 Viral Panel assay:
9
- A study to confirm equivalent analytical sensitivity with the FecalSwab by the limiting ● dilution LoD model was performed. 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% occurred at all the target stability time points claimed in the package insert. Therefore, stool preserved with FecalSwab can be stored for up to 120 hours (5 days) at 2 - 8 °C or for up to 48 hours at 2 - 25 °C, and sample buffer tube inoculated with FecalSwab specimen can be stored at 2 - 8 °C for a maximum of 120 hours (5 days) or at 2 - 25 ℃ for a maximum 48 hours (2 days).
- 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 Viral Panel.
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™ Viral Panel. Six (6) different users prepared two (2) different FecalSwab™ specimens from each of the five (5) panel members: (one (1) negative panel member, three (3) low-positive panel members, and one (1) moderate-positive panel member). The targets were selected to represent each of the PCR Master Mix formulations of the BD MAX Enteric Viral Panel. Norovirus was included because it is the most prevalent target of those in its Master Mix; Astrovirus was selected to represent the second master mix targets because it is the only target in the master mix that can be cultured. Once the FecalSwab™ specimens were prepared by various users, all subsequent steps, including the transfer to SBTs from each FecalSwabTM, were performed by a single experienced BD MAX™ user.
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 3).
| Target | Panel
Member | Acceptance
Criteria | Assay Results | Overall Result |
|------------|-----------------|------------------------|---------------|----------------|
| Norovirus | Low Positive | $\ge$ 95% POS | 100% POS | |
| | Moderate Pos | 100% POS | 100% POS | |
| | Negative | 100% NEG | 100% NEG | |
| Astrovirus | Low Positive | $\ge$ 95% POS | 100% POS | Pass |
| | Moderate Pos | 100% POS | 100% POS | |
| | Negative | 100% NEG | 100% NEG | |
Table 3: User Variability Study Results
The data demonstrate that expected assay results are obtained when FecalSwab stool specimens were prepared by multiple users.
11
- . The performance of the BD FecalSwab™ Collection, Transport and Preservation System when tested with the BD MAX™ Enteric Viral Panel was evaluated in a multicenter clinical study by comparing the results obtained for specimens using Cary-Blair Para-Pak® preserved stool samples to those using the 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 gastroenteritis, enteritis, or colitis from eight (8) geographically diverse clinical centers where specimens were collected as part of routine patient care. At these locations, a portion of the unpreserved stool samples were transferred into both Cary-Blair Para-Pak® collection vials and FecalSwab™ devices. Subsequently, the unpreserved stool sample, the inoculated Cary-Blair collection vial, and the inoculated FecalSwab™ device were shipped to a centralized testing laboratory and tested with the BD MAX™ Enteric Viral Panel. A total of 594 prospective specimens and 211 retrospective specimens were enrolled in the clinical evaluation. Three (3) prospective specimens were excluded from the data analysis due to specimen exclusion criteria. Table 4 describes the 802 (591 prospective and 211 retrospective) compliant specimens enrolled by patient age, sex, and specimen type. Ten (10) additional prospective samples were excluded from the data analysis due to Sample Buffer Tube or instrument level exclusion criteria. The final data analysis included 581 compliant prospective and 211 compliant retrospective subjects for Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Human Astrovirus (hAstro) targets.
| Specimen Type | Mean Age in
years (SD) | Median Age
in years | Min Age
in years | Max Age
in years | Sex of Total N |
|---------------------------------------------------------------------|---------------------------|------------------------|---------------------|---------------------|-----------------------------------------------|
| Prospective
Total N = 591
Unknown Age: 0
Known Age: 591 | 47.0 (22.7) | 49.0 |