The BD MAX Enteric Parasite Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection of enteric pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from:
Giardia lamblia
Cryptosporidium (C. hominis and C. parvum only), Entamoeba histolytica
Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, or colitis. The assay is intended to aid in the diagnosis of gastrontestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real- time polymerase chain reaction (PCR) for the amplification of specific targets. 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 Giardia lamblia, Cryptosporidium hominis, and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. 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 and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as colitis, irritable bowel syndrome, or Crohn's disease.

Device Description

The BD MAX™ Enteric Parasite 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. 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 MAX™ Enteric Parasite Panel, a test result may be called 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 MAXTM System failure.

AI/ML Overview

The provided text describes the BD MAX™ Enteric Parasite Panel, a diagnostic test for detecting specific parasitic nucleic acids in stool samples. The submission K220193 is a 510(k) premarket notification to add the Copan FecalSwab™ Collection, Preservation, and Transport System as an acceptable specimen type for use with the existing BD MAX™ Enteric Parasite Panel (predicate device K143648).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a table format with associated performance for the FecalSwab addition. Instead, it describes a series of studies designed to demonstrate that the performance of the device with FecalSwab specimens is equivalent or comparable to its performance with existing (unpreserved) specimen types. The core acceptance criterion for this submission is that the FecalSwab specimens perform similarly enough to unpreserved specimens to be considered "substantially equivalent."

Here's a summary of the reported performance from the studies aiming to demonstrate this equivalence:

Study/Criterion	Acceptance Metric (Implied)	Reported Device Performance (with FecalSwab)
Analytical Sensitivity (LoD)	LoD for FecalSwab fecal specimens should be similar to LoD of unpreserved stool specimens.	The same LoD values were obtained for the unpreserved specimens versus FecalSwab specimen for each of the three targets (Entamoeba histolytica, Cryptosporidium parvum, and Giardia lamblia), indicating equivalent analytical sensitivity.
Stability of Stool Specimens (FecalSwab)	Detection > 95% at target stability time points claimed in the package insert.	Detection > 95% occurred at all target stability time points. Stool preserved with FecalSwab can be stored for 48 hours (2 days) at 25 ± 2 °C and 120 hours (5 days) at 2 - 8 °C. Sample buffer tubes inoculated with FecalSwab specimen can be stored for 48 hours (2 days) at 25 ± 2 ℃ and 120 hours (5 days) at 2 - 8 ℃.
User Variability (FecalSwab Preparation)	Expected assay results should be obtained when FecalSwab stool specimens are prepared by multiple users.	The data demonstrate that expected assay results are obtained when FecalSwab stool specimens were prepared by multiple users.
Clinical Performance Comparison	Performance with FecalSwab specimen type should be comparable to the unpreserved stool specimen type.	Performance of the BD MAX™ Enteric Parasite Panel assay with the FecalSwab specimen type is comparable to the unpreserved stool specimen type (based on a comparison study of retrospectively collected clinical specimens and contrived specimens).

2. Sample sizes used for the test set and the data provenance

The document provides very limited detail on specific sample sizes for the test sets.

Analytical Sensitivity (LoD) Study: Not specified, but generally, LoD studies involve testing multiple replicates at various concentrations.
Stability Study: Not specified, but implies a sufficient number of samples across different storage conditions and time points to achieve > 95% detection.
User Variability Study: Not specified, but involved multiple users preparing FecalSwab tubes.
Clinical Performance Comparison Study: "retrospectively collected clinical specimens." The exact number of specimens is not provided.
- Data Provenance: Retrospective clinical specimens. The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily analytical and comparative evaluations of specimen types rather than diagnostic performance against a clinical ground truth established by experts. For the clinical comparison study, "retrospectively collected clinical specimens" were used, implying their original diagnostic status (positive/negative for specific parasites) served as a de facto ground truth, likely established by previous standard diagnostic methods or a combination of clinical and laboratory findings. No specific mention of experts or their qualifications for establishing this ground truth is made for this set of studies.

4. Adjudication method for the test set

The document does not mention any adjudication method. Since the studies focus on comparing a new specimen type to an existing one, the "truth" for the samples (especially in analytical studies) would be based on the known concentration of spiked organisms or the pre-established diagnostic status of clinical samples.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a molecular diagnostic test (PCR-based), not an AI-powered image analysis or interpretation tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this can be considered a standalone performance evaluation of the assay. The BD MAX™ System "automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR." The "software automatically interprets test results." There is no "human-in-the-loop" for the interpretation of the PCR results themselves beyond potentially reviewing unresolved or indeterminate results as per laboratory protocols. The studies evaluate the analytical and clinical performance of the automated system with different specimen inputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used depends on the specific study type:

Analytical Sensitivity (LoD): Likely based on known concentrations of target organisms spiked into fecal matrix, representing a quantitative "ground truth."
Stability Study: Similar to LoD, based on known concentrations of spiked organisms.
User Variability Study: Also likely based on known spiked concentrations in prepared samples.
Clinical Performance Comparison: The ground truth for the retrospectively collected clinical specimens would be their pre-established diagnostic status, which would typically arise from standard of care laboratory methods (e.g., microscopy, culture, or other molecular tests) and clinical presentation at the time of original diagnosis. The document states "performance of the BD MAX™ Enteric Parasite Panel assay with the FecalSwab specimen type is comparable to the unpreserved stool specimen type," implying the original diagnosis on the unpreserved samples (or the consensus of prior methods) served as the comparator.

8. The sample size for the training set

The document does not specify a training set sample size. This submission is for an updated specimen claim for an existing device (BD MAX™ Enteric Parasite Panel, K143648), not the initial development or de novo training of the core algorithm. The studies conducted here are primarily validation/verification studies for the FecalSwab specimen type.

9. How the ground truth for the training set was established

Since no specific training set is mentioned for this particular submission (K220193), the method for establishing ground truth for a training set is not applicable to the information provided. The original predicate device (K143648) would have undergone its own development and validation, which would have involved establishing ground truth for its analytical and clinical studies.

Summary

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August 19, 2022

Becton, Dickinson and Company Joseph Basore Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152

Re: K220193

Trade/Device Name: BD MAX Enteric Parasite 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: January 21, 2022 Received: January 24, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220193

Device Name BD MAX Enteric Parasite Panel

Indications for Use (Describe)

Giardia lamblia

Cryptosporidium (C. hominis and C. parvum only), Entamoeba histolytica

Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, or colitis. The assay is intended to aid in the diagnosis of gastrontestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real- time polymerase chain reaction (PCR) for the amplification of specific targets. 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 Giardia lamblia, Cryptosporidium hominis, and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. 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 and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as colitis, irritable bowel syndrome, or Crohn's disease.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

BD MAX™ Enteric Parasite Panel

Summary Preparation Date:

01/21/2022

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 Parasite Panel

Common Names:

For the instrument:

Bench-top molecular diagnostics workstation

For the assay:

Enteric Parasite Nucleic Acid Test Enteric Parasite identification and differentiation system Enteric assay Enteric test

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Regulatory Information

Regulation section:

3990 - Gastrointestinal microorganism multiplex nucleic acid-based assay

Classification:

Class II

Panel:

Microbiology (83)

Product Code(s):

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PHC Real Time Nucleic Acid Amplification System 00I

Predicate Device

BD MAXTM Enteric Parasite Panel (K143648)

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 Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric parasitic pathogens. The BD MAXTM Enteric Parasite Panel detects nucleic acids from:

Giardia lamblia
Cryptosporidium (C. hominis and C. parvum only)
Entamoeba histolytica

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Testing is performed on unpreserved or 10% formalin-fixed stool specimens or FecalSwab™ specimens from symptomatic patients with suspected gastroenteritis, enteritis or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen. utilizing real-time polymerase chain reaction (PCR) for the amplification of specific targets. 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 Giardia lamblia, Cryptosporidium hominis, and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. 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 and/or colitis 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 Parasite Panel is performed on the BD MAXTM System

Device Description

Test Principle

The BD MAXTM Enteric Parasite Panel is designed for use with unpreserved or 10% Formalin preserved stool samples or FecalSwab™ specimens. 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 10% Formalin preserved specimen claim utilizes a plastic paddle (scoop) to place a stool sample into 15 ml of 10% Formalin media for transport before being placed into a SBT with a 10 uL transfer loop prior to analysis on the BD MAX™ System.

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To use the FecalSwab™ Collection. Transport, and Preservation System, the operator transfers fecal material from an unpreserved stool specimen to the FecalSwab™ transport medium tube using the nylon flocked specimen collection swab. The FecalSwab™ transport medium tube is filled with 2 ml of a semi-solid 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 (150 ul) into a BD MAX™ sample buffer tube (SBT).

Once specimens (Unpreserved, 10% Formalin, or FecalSwab) are placed into a BD MAX™ SBT, the principles of the test are as described in K143648. For all specimen types the SBTs are heated on the BD Prewarm heater to facilitate lysis of the parasite organisms. Following heating, 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 automated procedures begin.

Microbial cells are lysed and DNA 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 high pH in elution buffer. 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 to contain the amplification mixture and thus preventing evaporation and contamination.

The amplified DNA targets are detected using hydrolysis (TagMan®) 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 (amplicons) for enteric parasite targets and the Sample Processing Control in four different optical channels of the BD MAXIM 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 Parasite Panel is 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 inhibitors.

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Substantial Equivalence1

Table 1 provides the similarities and differences between the submitted device and the legally marketed predicate device.

l 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 and as applied under which a device can be marketed without pre-market approval or reclassification of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or the courts.

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Item	Predicate - BD MAXTM Enteric Parasite Panel(K143648)	Proposed - BD MAXTM Enteric Parasite Panelwith Copan FecalSwabTM Collection,Preservation, and Transport System
Intended Use	The BD MAXTM Enteric Parasite Panel performed onthe BD MAXTM System is an automated in vitrodiagnostic test for the direct qualitative detection ofenteric parasite pathogens. The BD MAXTM EntericParasite Panel detects nucleic acids from:	The BD MAXTM Enteric Parasite Panel performed onthe BD MAXTM System is an automated in vitrodiagnostic test for the direct qualitative detection ofenteric parasitic pathogens. The BD MAXTM EntericParasite Panel detects nucleic acids from:
	• Giardia lamblia	• Giardia lamblia
	• Cryptosporidium (C. hominis and C. parvum only)	• Cryptosporidium (C. hominis and C. parvum only)
	• Entamoeba histolytica	• Entamoeba histolytica
	Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients withsuspected gastroenteritis, enteritis or colitis. The test isintended to aid in the diagnosis of gastrointestinalinfection when used in conjunction with clinicalevaluation and other laboratory findings. The test isperformed directly on the specimen, utilizing real-timepolymerase chain reaction (PCR) for the amplificationof specific targets. The test utilizes fluorogenic gene-specific hybridization probes for detection of theamplified DNA.	Testing is performed on unpreserved or 10%formalin-fixed stool specimens or FecalSwabTMspecimens from symptomatic patients with suspectedgastroenteritis, enteritis or colitis. The assay isintended to aid in the diagnosis of gastrointestinalinfection when used in conjunction with clinicalevaluation and other laboratory findings. The test isperformed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for theamplification of specific targets. The test utilizesfluorogenic gene-specific hybridization probes fordetection of the amplified DNA.
	This test is intended for use, in conjunction with clinicalpresentation, laboratory findings, and epidemiologicalinformation, as an aid in the differential diagnosis ofGiardia lamblia, Cryptosporidium hominis and C.parvum, as well as Entamoeba histolytica infections.Results of this test should not be used as the sole basisfor diagnosis, treatment, or other patient managementdecision. Positive results do not rule out co-infectionwith other organisms that are not detected by this test.	This test is intended for use, in conjunction withclinical presentation, laboratory findings, andepidemiological information, as an aid in thedifferential diagnosis of Giardia lamblia,Cryptosporidium hominis, and C. parvum, as well asEntamoeba histolytica infections. Results of this testshould not be used as the sole basis for diagnosis,treatment, or other patient management decision.
Item	Predicate - BD MAX™ Enteric Parasite Panel(K143648)	Proposed - BD MAX™ Enteric Parasite Panelwith Copan FecalSwab™ Collection,Preservation, and Transport System
	and may not be the sole or definitive cause of patientillness. Negative results in the setting of clinical illnesscompatible with gastroenteritis and/or colitis may be dueto infection by pathogens that are not detected by thistest or non-infectious causes such as ulcerative colitis,irritable bowel syndrome, or Crohn's disease.	Positive results do not rule out co-infection withother organisms that are not detected by this test, andmay not be the sole or definitive cause of patientillness. Negative results in the setting of clinicalillness compatible with gastroenteritis and/or colitismay be due to infection by pathogens that are notdetected by this test or non-infectious causes such asulcerative colitis, irritable bowel syndrome, orCrohn's disease.
Organisms Detected	• Giardia lamblia• Cryptosporidium ( C. hominis and C. parvum only)• Entamoeba histolytica	Same


Specimen Type	Unpreserved stool or 10% formalin-fixed	Unpreserved stool or 10% formalin-fixed orFecalSwab specimens
Assay Format	Amplification: PCRDetection: Fluorogenic target-specific hybridization	Same
Mode of Detection	Presence of• SSU rRNA gene specific for Giardia lamblia	Same
	• sequence contained within the Laxer locus specific forCryptosporidium ( C. hominis and C. parvum only)
	• SSU rRNA gene specific for Entamoeba histolytica
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
Item	Predicate - BD MAX™ Enteric Parasite Panel(K143648)	Proposed - BD MAX™ Enteric Parasite Panelwith Copan FecalSwab™ Collection,Preservation, and Transport System
Preservation BufferFormulation	Formalin-fixed: 10 % FormalinUnpreserved: None	Formalin-fixed: SameUnpreserved: SameFecalSwab:• Sodium Chloride• Calcium Chloride• Phosphate Buffer• L-Cysteine• Agar• Water
Preservation Buffer Container	• Formalin-fixed: Plastic Container w/Lid prefilled 15 ml of media.• Unpreserved: Not Applicable	• Formalin-fixed: Plastic Container w/Lid prefilled 15 ml of media.• Unpreserved: Not Applicable• FecalSwab: Plastic Container w/Lid prefilled 2 ml of media
Transfer Tool to PreservationBuffer	• Formalin-fixed: Plastic Paddle• Unpreserved: Not Applicable	• Formalin-fixed: Plastic Paddle• Unpreserved: Not Applicable• FecalSwab: Flocked Swab
Transport Method to SBTTube	• Formalin-fixed: 10 µL Transport Loop• Unpreserved: 10 µL Transport Loop	• Formalin-fixed: Same• Unpreserved: Same• FecalSwab: 150 µL Pipette
Sterile	• Formalin-fixed: Not Applicable• Unpreserved: Not Applicable	• Formalin-fixed: Same• Unpreserved: Same• FecalSwab: Yes, Irradiation

Comparison of BD MAX™ Enteric Parasite Panel with FecalSwab to Predicate Device Table 1:

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Performance Evaluation

Four studies were conducted to demonstrate the substantial equivalence between the predicate specimen collection (Unpreserved) and the additional specimen collection (FecalSwab) for use in the BD MAX™ Enteric Parasite Panel assay:

A study was performed to confirm equivalent analytical sensitivity with the ● FecalSwab. This study demonstrates that the LoD for FecalSwab fecal specimens is similar to the LoD of unpreserved stool specimens. The same LoD values were obtained for the unpreserved specimens in this study versus FecalSwab specimen for each of the three targets, Entamoeba histolytica, Cryptosporidium parvum and Giardia lamblia, indicating the analytical sensitivity is equivalent.
Stability of stool specimens collected with the FecalSwab was tested against all target organisms. The results showed that the stability of FecalSwab specimens meets the current BD MAXTM Enteric Parasite Panel claims. For each organism tested across the BD MAX™ Enteric Parasite Panel, a detection > 95% occurred at all the target stability time points claimed in the package insert. Therefore, stool preserved with FecalSwab can be stored for 48 hours (2 days) at 25 ± 2 °C and 120 hours (5 days) at 2 - 8 °C, and sample buffer tube inoculated with FecalSwab specimen can be stored for 48 hours (2 days) at 25 ± 2 ℃ and 120 hours (5 days) at 2 - 8 ℃.
. A user variability study was performed to determine if the transfer of unpreserved stool to FecalSwab tubes by different users induced variability. The preparation of unpreserved stool panels prior to FecalSwab transfer and all steps subsequent to FecalSwab preparation, including the transfer to SBTs from each FecalSwab, were performed by a single experienced BD MAX™ user. The data demonstrate that expected assay results are obtained when FecalSwab stool specimens were prepared bv multiple users.
. A comparison study of retrospectively collected clinical specimens was performed using the cleared collection device (unpreserved) and the new collection device (FecalSwab) with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The results of this study, along with evaluation of contrived clinical specimens, where applicable, demonstrated that performance of the BD MAX™ Enteric Parasite Panel assay with the FecalSwab specimen type is comparable to the unpreserved stool specimen type.

Regulation Number and Section

§ 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).