(210 days)
Not Found
No
The description focuses on automated PCR and real-time detection with software interpretation based on amplification status, which are standard features of molecular diagnostic systems and do not indicate the use of AI/ML.
No
This device is an in vitro diagnostic test designed to detect and differentiate enteric bacterial pathogens, aiding in diagnosis. It does not provide treatment or modify bodily functions, which are characteristics of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel are "automated in vitro diagnostic test[s]" and are "intended for use...as an aid in the differential diagnosis of..." various infections.
No
The device description explicitly states that the system is comprised of an instrument with associated hardware and accessories, disposable cartridges, reagents, and extraction reagents, in addition to the software. This indicates it is a hardware and software system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section for both the BD MAX™ Enteric Bacterial Panel and the BD MAX™ Extended Enteric Bacterial Panel that they are "automated in vitro diagnostic test[s]".
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PCI, PCH, OOI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stool specimens
Indicated Patient Age Range
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.
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
1
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
2
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.
3
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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4
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.
6
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
7
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
8
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.
9
| Comparison of BD MAX™ Enteric Bacterial Panel to Predicate Device
| Table 1: | |
|---|---|
| ------------------------------------------------------------------------------- | -- |
| Item | Predicate - BD MAX™ Enteric Bacterial Panel (K140111) | Submitted Device - BD MAXTM
Enteric Bacterial Panel with
FecalSwab Collection,
Preservation, and Transport
System |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 ( 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-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. | Same |
| Item | Predicate - BD MAX™ Enteric Bacterial Panel (K140111) | Submitted Device - BD MAX™
Enteric Bacterial Panel with
FecalSwab Collection,
Preservation, and Transport
System |
| 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: PCR
Detection: 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 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 |
| Cary-Blair Buffer
Formulation | -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 Buffer
Container | Plastic Container w/Lid prefilled 15 ml of media | Plastic Container w/Lid prefilled
2 ml of media |
| Item | Predicate - BD MAXTM Enteric Bacterial Panel (K140111) | Submitted Device - BD MAXTM
Enteric Bacterial Panel with
FecalSwab Collection,
Preservation, and Transport
System |
| Specimen Transfer
Tool (unpreserved to
Cary-Blair) | Plastic Paddle | Flocked Swab |
| Transport Method to
SBT Tube | 10 µL Transport Loop | 50 µL Pipette |
| Sterility of
FecalSwab | Not Applicable | Yes, Irradiation (FecalSwab) |
10
11
12
| Item | Predicate - BD MAX Extended Enteric Bacterial Panel (K170308) | Proposed - BD MAX Extended
Enteric Bacterial Panel with
FecalSwab Collection,
Preservation, and Transport
System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD MAXTM Extended Enteric Bacterial Panel performed on the BD MAXTM
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 MAXTM Enteric Bacterial Panel as an optional Master Mix. The BD MAXTM
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. | Same |
| | 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 | |
| Item | Predicate - BD MAX Extended Enteric Bacterial Panel (K170308) | Proposed - BD MAX Extended
Enteric Bacterial Panel with
FecalSwab Collection,
Preservation, and Transport
System |
| | by pathogens that are not detected by this test or non-infectious causes such as
ulcerative 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-stable
enterotoxin (ST) genes
• Yersinia enterocolitica | Same |
| Specimen Type | Unpreserved stool or Cary-Blair preserved stool | Same |
| Assay Format | Amplification: PCR
Detection: 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 Test
Results | Automated (BD MAXTM System diagnostic software) | Same |
| Analysis Platform | BD MAXTM System | Same |
| PCR Sample
Preparation | Automated by the BD MAXTM System | Same |
| Detection Probes | TaqMan® Probe | Same |
| Assay Controls | Sample Processing Control (SPC) | Same |
| Cary-Blair Buffer
Formulation | Sodium Chloride
Calcium Chloride
Phosphate Buffer
Thioglycolic Acid Sodium Salt
Phenol Red
Agar
Water | -Chloride salts
-Sodium salts
-Phosphate buffer
-L-Cysteine
-Agar
-Water |
| Item | Predicate - BD MAX Extended Enteric Bacterial Panel (K170308) | Proposed - BD MAX Extended
Enteric Bacterial Panel with
FecalSwab Collection,
Preservation, and Transport
System |
| Cary-Blair Buffer
Container | Plastic Container w/Lid prefilled 15 ml of media | Plastic Container w/Lid prefilled 2
ml of media |
| Transfer Tool | Plastic Paddle | Nylon Flocked Swab |
| Transport Method to
SBT Tube | Transport Loop | Pipette |
| Sterility of
FecalSwab | Not Applicable | Yes, Irradiation (FecalSwab) |
Table 2: Comparison of BD MAX™ Extended Enteric Bacterial Panel to Predicate Device
13
14
15
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 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).
20
| 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).
21
| 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 Available | ||||
| NPA: 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).
23
| 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).
24
| 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
| Plesiomonas
| shigelloides | 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
| Yersinia
| enterocolitica | 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%) |