The BD FACSCanto flow cytometer (4-3-3 configuration) functions as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (640 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III.

For in vitro diagnostic use.

The BD FACSCanto II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III.

For in vitro diagnostic use.

Device Description

The BD FACSCanto and FACSCanto II (BD FACSCanto II 4-2-2, BD FACSCanto II 5-3 and BD FACSCanto 4-3-3 configurations) are comprised of a flow cytometer, a fluidics cart, and a computer workstation. The flow cytometer acquires and analyzes the sample, the fluidics cart contains operational fluids, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping assays prepared using the lyse/wash or lyse/no-wash methods, and BD FACSDiva software for installation, service, and manual user-validated applications. The BD FACSCanto and FACSCanto II systems can optionally be used with the BD FACSLoader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software and BD FACSDiva software, and/or the BD FACS Sample Prep Assistant III for automatic sample preparation of assays utilizing the lyse/no-wash method.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BD FACSCanto and BD FACSCanto II flow cytometers. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The document outlines comparisons between the new configurations and the predicate devices, with emphasis on the performance of IVD (In Vitro Diagnostic) channels.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., a required sensitivity or specificity threshold) with corresponding reported device performance values for the new configurations compared to the predicate device. Instead, it states that the new configurations demonstrated "equivalent performance to the predicate" for various studies. This "equivalent performance" implicitly serves as the acceptance criterion.

Study Type	Acceptance Criteria (Implicit)	Reported Device Performance
Accuracy/Method Comparison	Equivalent performance to the predicate device.	The BD FACSCanto II system 4-2-2 and 5-3 configurations and BD FACSCanto system 4-3-3 configuration demonstrated equivalent performance to the predicate for the BD Multitest™ IMK Kit (4-color) and BD Multitest™ 6-color TBNK (with Trucount™) assays.
Precision	Equivalent performance to the predicate device.	Assay dependent. The BD FACSCanto II system 4-2-2 and 5-3 configurations and BD FACSCanto system 4-3-3 configuration demonstrated equivalent performance to the predicate for the BD Multitest IMK Kit (4-color) and BD Multitest 6-color TBNK (with Trucount) assays.
Linearity	Equivalent performance to the predicate device.	Assay- dependent. The BD FACSCanto II system 4-2-2 and 5-3 configurations and BD FACSCanto system 4-3-3 configuration demonstrated equivalent performance to the predicate for the BD Multitest IMK Kit (4-color) and BD Multitest 6-color TBNK (with Trucount) assays.
Carryover	Mean carryover met the acceptance criteria described (unspecified).	The mean carryover measured from manual acquisition and the mean carryover from Loader acquisition both met the acceptance criteria described. (The specific numerical acceptance criteria for carryover are not provided in the document, but the device reportedly met them.)

2. Sample Sizes Used for the Test Set and Data Provenance

The document refers to "patient samples" for the Accuracy/Method Comparison study, "assay dependent" for Precision and Linearity, and "Three samples with a high White Blood Cell concentration" and "three low WBC concentration samples" for the Carryover study.

Accuracy/Method Comparison: "patient samples" - The specific number of samples is not provided. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical samples for IVD assays.
Precision: "Assay dependent" - Specific sample size is not provided. Data provenance is not explicitly stated.
Linearity: "Assay- dependent" - Specific sample size is not provided. Data provenance is not explicitly stated.
Carryover: 6 samples (3 high WBC, 3 low WBC) - Data provenance is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies performed are instrument performance evaluations, comparing the new device configurations to the predicate device, rather than comparing to a diagnostic ground truth established by experts. The "ground truth" implicitly relies on the established performance of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the studies are technical performance comparisons of the device itself rather than interpretation by human readers, an adjudication method in the context of expert review would likely not be applicable.

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

This document describes a flow cytometer, which is an instrument for identifying and enumerating cell subsets. It is not an AI-assisted diagnostic tool that human readers would use to interpret images or data in a comparative effectiveness study involving improving diagnostic accuracy. Therefore, an MRMC comparative effectiveness study with human readers improving with AI assistance is not applicable and was not done in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone instrument (flow cytometer) with dedicated clinical software. The performance data presented (accuracy/method comparison, precision, linearity, carryover) represents the standalone performance of the instrument configurations (new vs. predicate). There is no "human-in-the-loop" aspect being evaluated in these specific performance studies, as the instrument performs the measurement and analysis for IVD assays.

7. The Type of Ground Truth Used

For the performance studies (Accuracy/Method Comparison, Precision, Linearity), the "ground truth" is effectively the performance of the legally marketed predicate device (BD FACSCanto 4-2 configuration), as the goal is to demonstrate "equivalent performance." For the Carryover study, the ground truth would be the actual concentration values and the calculated carryover, which is an intrinsic characteristic of the instrument's fluidics and detection system.

8. The Sample Size for the Training Set

This information is not provided. The document describes new configurations of an existing flow cytometer system and its software, demonstrating substantial equivalence to a predicate device. It does not mention machine learning or AI models undergoing a 'training' phase in the traditional sense, for which a training set size would be relevant. The software performs automated immunophenotyping based on established algorithms rather than adaptive learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of machine learning is not mentioned as part of this submission, the method for establishing its ground truth is not applicable/not provided. The software algorithms integral to the device's function are based on engineering design and validation, not on a machine learning training paradigm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a cascading manner. The profiles are connected by a flowing line that forms a wave-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 11, 2016

BD Biosciences % Ms. Elizabeth Landon Staff Regulatory Affairs Specialist 2350 Qume Drive San Jose, California 95131

Re: K141468 Trade/Device Name: BD FACSCanto flow cytometer (4-3-3 configuration) with BD FACSCanto clinical software and BD FACSDiva software and BD FACSCanto II flow cytometers (4-2-2 and 5-3 configurations) with BD FACSCanto clinical software and BD FACSDiva software Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: OYE Dated: January 26, 2015 Received: January 27, 2015

Dear Ms. Landon:

This letter corrects our substantially equivalent letter of February 27, 2015.

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. 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 vour 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809] ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 8091 ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR

Leonthena R. Carrington, MS. MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141468

Device Name

BD FACSCanto™ flow cytometer (4-3-3 configuration) with BD FACSCanto™ clinical software and BD FACSDiva™ software

Indications for Use (Describe)

For in vitro diagnostic use.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K141468

Device Name

BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) with BD FACSCanto™ clinical software and BD FACSDiva™ software

Indications for Use (Describe)

For in vitro diagnostic use.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Date of Summary: Feb. 26, 2015

5.1 Submitted By

BD Biosciences 2350 Oume Drive San Jose, CA 95131-1807 USA

Elizabeth Landon, Staff Regulatory Affairs Specialist Contact: Telephone: (408) 954-4149 (408) 954-2347 Fax: elizabeth_landon@BD.com Email:

5.2 Trade Name/Device Name: BD FACSCanto" flow cytometer (4-3-3 configuration ) with BD FACSCanto™ clinical software and BD FACSDiva™ software and
BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) with BD FACSCanto The clinical software and BD FACSDiva™ software

Classification:	Class II
Classification Name:	Automated Differential Cell Counter
Classification Panel:	Hematology and Pathology Devices Panel
Classification Code:	OYE
Regulation:	21 CFR 864.5220

5.3 Indications for Use

Device Name: BD FACSCanto II flow cytometers (4-2-2 and 5-3 configurations) with BD FACSCanto™ clinical software and BD FACSDiva"M software

The BD FACSCanto " II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS 100 Sample Prep Assistant III.

For in vitro diagnostic use.

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Device Name: BD FACSCanto" flow cytometer (4-3-3 configuration ) with BD FACSCanto™ clinical software and BD FACSDiva™ software

The BD FACSCanto™ flow cytometer (4-3-3 configuration) functions as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (640 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS "" Sample Prep Assistant III.

For in vitro diagnostic use.

5.4 Basic Description of the Device

The BD FACSCanto II system is available in three configurations. The base "4-2" configuration model (cleared by K062087) contains two lasers (blue and red) and seven photomultiplier tubes (PMTs); the "5-3" and "4-2-2" configuration models contain the same two lasers (blue and red). The systems have two additional PMTs for a total of nine. Additionally, the 4-2-2 model is also manufactured with a 405-nm violet laser. The 5-3 and 4-2-2 configurations support the detection of additional fluorochromes for research applications. Only six detection channels using the red and blue lasers within these models can be used with IVD assays. The performance between the three configurations in their detection of forward scatter (FSC), side scatter (SSC), and the six common fluorochromes are the same and performance and clinical data show equivalent results for the IVD assays. The only difference is in their capability to detect an additional seventh or eighth fluorescence parameter for research use only applications.

The BD FACSCanto system is available in two configurations. The base "4-2" configuration model (cleared by K040725 and K041074) contains two lasers (blue and red) and seven photomultiplier tubes (PMTs); the "4-3-3" configuration model

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contains blue and red lasers as well. The 4-3-3 configuration has four additional PMTs for a total of eleven. Additionally, the 4-3-3 configuration is manufactured with a 405-nm violet laser, which is the same laser used within the BD FACSCanto II family. This violet laser supports the detection of additional fluorochromes for research applications. Only six detection channels using the red and blue lasers within this model can be used with IVD assays. The performance between the two configurations in their detection of forward scatter (FSC), side scatter (SSC), and the six common fluorochromes are the same and performance and clinical data show equivalent results for the IVD assays. The only difference is in their capability is to detect additional fluorescence parameters (up to 10 colors and 12 parameters) for research use only applications.

Table 5-1: Instrument Configurations of BD FACSCanto II
Model	Lasers	Optics andParameter/Fluorochrome

Model	Lasers	Optics andParameter/FluorochromeDetection
BD FACSCanto II 4-2(reference device)	488-nm (blue)633-nm (red)	7 photomultiplier tubesParameter detection: FSC, SSC, sixfluorochromes
BD FACSCanto II 5-3	488-nm (blue)633-nm (red)	9 photomultiplier tubesParameter detection: FSC, SSC,eight fluorochromes
BD FACSCanto II 4-2-2	405-nm (violet)488-nm (blue)633-nm (red)	9 photomultiplier tubesParameter detection: FSC, SSC,eight fluorochromes

Table 5-2: Instrument Configurations of BD FACSCanto

Model	Lasers	Optics andParameter/FluorochromeDetection
BD FACSCanto 4-2(predicate device)	488-nm (blue)633-nm (red)	7 photomultiplier tubesParameter detection: FSC, SSC, sixfluorochromes
BD FACSCanto 4-3-3	405-nm (violet)488-nm (blue)640-nm (red)	11 photomultiplier tubesParameter detection: FSC, SSC, tenfluorochromes

The performance of these configurations in their detection of forward scatter (FSC), side scatter (SSC), and the six common fluorochromes is equivalent to the predicate BD FACSCanto 4-2 configuration. The only difference is in their capability to detect additional fluorescence parameters (for research use only).

The IVD applications/assays remain unchanged and perform equivalently across configurations.

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5.5 Predicate Device

BD FACSCanto system (4-2 configuration) with BD FACSCanto clinical software and BD FACSDiva software (premarket notifications K041074 and K040725 respectively).

5.6 Reference Device

BD FACSCanto II system (4-2 configuration) with BD FACSCanto clinical software and BD FACSDiva software (K062087).

5.7 Predicate Device and Reference Device Selection Rationale

The BD FACSCanto 4-2 configuration (cleared with K041074 and K040725) is chosen as predicate since the subsequent configurations were based on the same starting platform and it was representative to all three devices in the submission. Additionally, the BD FACSCanto II 4-2 configuration is used as a reference device since all the changes made in BD FACSCanto II platform, which includes the 5-3 and 4-2-2 configurations, were cleared in K062087.

5.8 Comparison to the Predicate - Similarities and Differences

5.8.1 Intended Use

Intended use statements are noted in Table 5-3 below.

5.8.2 Technological Characteristics

The technological differences between the BD FACSCanto II 5-3, BD FACSCanto II 4-2-2, and BD FACSCanto 4-3-3 configurations and the BD FACSCanto system 4-2 configuration are in the areas of optics and detection capability. The primary changes are additional detectors and a third laser to expand research use parameters.

The performance of the IVD channels, using IVD assays, has been verified to be equivalent between all configurations against the predicate BD FACSCanto system 4-2 configuration.

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Feature/Attribute	BD FACSCanto (4-2):Predicate Device	BD FACSCanto II (4-2):Reference Device	BD FACSCanto II(5-3)	BD FACSCanto II(4-2-2)	BD FACSCanto(4-3-3)
Intended Use	The BD FACSCanto (4-2)system is intended for use asin vitro diagnostic devices forthe identification andenumeration of lymphocytesubsets in human cells insuspension.Immunophenotyping inclinical laboratories,using previously clearedin vitro diagnostic assaysfor flow cytometry. Identification andenumeration oflymphocyte subsets inhuman cells insuspension. For in vitro diagnosticuse. For use with or withoutthe BD FACS SamplePrep Assistant II.	The BD FACSCanto II(4-2) system is intendedfor use as in vitrodiagnostic devices for theidentification andenumeration oflymphocyte subsets inhuman cells insuspension.Immunophenotypingin clinicallaboratories, usingpreviously cleared invitro diagnosticassays for flowcytometry. Identification andenumeration oflymphocyte subsetsin human cells insuspension. For in vitrodiagnostic use. For use with orwithout the BDFACS Sample PrepAssistant III	The BD FACSCanto IIflow cytometers (4-2-2,and 5-3 configurations)function as part of asystem with dedicatedclinical softwareintended for use withcleared or approved invitro diagnostic (IVD)assays that are indicatedfor use with theinstrument for theidentification andenumeration of humancell subsets. Only sixdetection channels usinga blue (488 nm) and ared (633 nm) laser havebeen cleared for in vitrodiagnostic use.For usewith or without the BDFACS Sample PrepAssistant III.For in vitro diagnosticuse.	Same as BDFACSCanto II (5-3)	The BD FACSCanto flowcytometer (4-3-3configuration) functionsas part of a system withdedicated clinicalsoftware intended for usewith cleared or approvedin vitro diagnostic (IVD)assays that are indicatedfor use with theinstrument for theidentification andenumeration of humancell subsets. Only sixdetection channels using ablue (488 nm) and a red(640 nm) laser have beencleared for in vitrodiagnostic use.For usewith or without the BDFACS Sample PrepAssistant III.For in vitro diagnosticuse.
Device Classificationand Product Code	Automated Differential CellCounter 21 CDR 864.5220Product Code: OYE	Same	Same	Same	Same
Feature/Attribute	BD FACSCanto (4-2):Predicate Device	BD FACSCanto II (4-2):Reference Device	BD FACSCanto II(5-3)	BD FACSCanto II(4-2-2)	BD FACSCanto(4-3-3)
IVD Excitation	Blue laser488nm solid state, 20mW	Blue laserSame	Blue laserSame	Blue laserSame	Blue laserSame
	Red laser633nm HeNe, 17mW	Red laserSame	Red laserSame	Red laserSame	Red laser640nm solid state, 40mW
IVD Optical Detection	1st detector arrayBlue “octagon” receives488nm-excited and scatteredlight. The array is configuredto detect SSC and 4fluorochromes (FITC, PE,PerCP/PerCP-Cy5.5, PE-Cy7)	1st detector arraymodified to enableadditional detectors in 5-3configuration	1st detector array sameas BD FACSCanto II 4-2configuration but anadditional detector isenabled	1st detector arraysame as BDFACSCanto II 4-2configuration	1st detector arraysimilar to BD FACSCanto4-2 configuration withminor filter modification.
	2nd detector arrayRed “trigon” receives 633nm-excited light. The array isconfigured to detect 2fluorochromes (APC, APC-Cy7)	2nd detector arraymodified to enableadditional detectors in 5-3configuration	2nd detector arraysame as BD FACSCantoII 4-2 configuration butan additional detector isenabled	2nd detector arraysame as BDFACSCanto II 4-2configuration	2nd detector arraysimilar to BD FACSCantoII 4-2 configuration, withminor filter modification.An additional detector isenabled.
Electronics	Electronics boards containingacquisition electronicscomponents	Electronics board withimproved preamplifiercircuitry.	Same as BD FACSCantoII 4-2 configuration.	Same as BDFACSCanto II 4-2configuration.	Similar to BDFACSCanto 4-2 withmodifications to the pre-amplifier circuitry.
Feature/Attribute	BD FACSCanto (4-2):Predicate Device	BD FACSCanto II (4-2):Reference Device	BD FACSCanto II(5-3)	BD FACSCanto II(4-2-2)	BD FACSCanto(4-3-3)
Fluidics	Consists of a pinch valveassembly which controls theflow of sample, saline, andwaste fluids. Includes aseparate wet cart assembly.	Consists of a block thatduplicates FACSCantofluidic scheme. Use ofmanifold improvesreliability and ease ofserviceability.	Same as BD FACSCantoII 4-2 configuration.	Same as BDFACSCanto II 4-2configuration.	Same as BD FACSCantoII 4-2 configuration.
Fluidics Cart	Original FACSCanto designwith FACSFlow™ sheathfluid cubitainer	BD FACSCanto fluidicscart with theincorporation of amanifold assembly andimproved chemicalcompatibility of valvematerial.	Same as BD FACSCantoII 4-2 configuration.	Same as BDFACSCanto II 4-2configuration.	Same as BD FACSCantoII 4-2 configuration.
Sample Introduction	Original FACSCanto Sampleinjection tube (SIT) design	SIT with modified tubeguide, sensor, and probetip	Same as BD FACSCantoII 4-2 configuration.	Same as BDFACSCanto II 4-2configuration.	Same as BD FACSCanto4-2
Automated SamplePresentation	BD FACSLoader	BD FACSLoader withupdated motor, pneumaticactuation, and slidingaccess doors	Same as BD FACSCantoII 4-2 configuration.	Same as BDFACSCanto II 4-2configuration.	Same as BD FACSCanto4-2
Software	BD FACSCanto clinicalsoftware v1.0 or higherBD FACSDiva software v4.0or higher	BD FACSCanto clinicalsoftware v2.1 or higher(currently v3.0)BD FACSDiva softwarev5.0.1 or higher	Same as BD FACSCantoII 4-2 configuration(currently v3.0).	Same as BDFACSCanto II 4-2configuration(currently v3.0).	BD FACSCanto clinicalsoftware v2.4 or higher(currently v3.0)BD FACSDiva softwarev7.0 or higher.
Instrument Setup andQuality Control	Automated setup using BDFACSCanto clinical softwareand BD FACS 7-color setupbeads	Same	Same	Same	Same
Sample Preparation	Manual pipetting for thelyse/wash or lyse/no-washmethods, or automated withthe BD FACS Sample PrepAssistant (SPA) for thelyse/no-wash method	Same	Same	Same	Same
Sample Type*	Assay-dependent	Same	Same	Same	Same
*Sample Types are assay-dependent; refer to FDA-cleared assays for designated sample types. For use with Multitest 6-color TBNK and IMK kit, whole blood is the

Table 5-3: Similarities/Differences - Predicate and reference devices (BD FACSCanto II 4-2) against subject devices (BD FACSCanto II 5-3, BDFACSCanto II 4-2-2 and BD FACSCanto 4-3-3]

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5.9 Substantial Equivalence

Performance of the different configurations of the BD FACSCanto and BD FACSCanto II is equivalent. All instruments have similar intended uses and similar operating principles; any differences in technological characteristics are accompanied by information that demonstrates the devices are as safe and effective as the predicate device configuration. Therefore, these devices are substantially equivalent to the predicate, the BD FACSCanto 4-2 flow cytometry system.

5.10 Performance Data

Study	Study Design	Results
Accuracy/MethodComparison	Based on Method Comparison andBias Estimation Using PatientSamples, CLSI document EP9-A2.	The BD FACSCanto II system 4-2-2 and5-3 configurations and BD FACSCantosystem 4-3-3 configuration demonstratedequivalent performance to the predicatefor the BD MultitestTM IMK Kit (4-color) and BD MultitestTM 6-colorTBNK (with TrucountTM) assays.
Precision	Based on Evaluation of PrecisionPerformance of Clinical ChemistryDevices, CLSI document EP5-A2.	Assay dependent. The BD FACSCanto IIsystem 4-2-2 and 5-3 configurations andBD FACSCanto system 4-3-3configuration demonstrated equivalentperformance to the predicate for the BDMultitest IMK Kit (4-color) and BDMultitest 6-color TBNK (with Trucount)assays.
Linearity	Based on Evaluation of theLinearity of QuantitativeMeasurement Approaches: AStatistical Approach, CLSIdocument EP6-A.	Assay- dependent. The BD FACSCantoII system 4-2-2 and 5-3 configurationsand BD FACSCanto system 4-3-3configuration demonstrated equivalentperformance to the predicate for the BDMultitest IMK Kit (4-color) and BDMultitest 6-color TBNK (with Trucount)assays.
Carryover	Three samples with a high WhiteBlood Cell concentration wereacquired, followed by three lowWBC concentration samples.Carryover Calculation:$100% * [ (L1-L3) / (H3-L3) ]$	The mean carryover measured frommanual acquisition and the meancarryover from Loader acquisition bothmet the acceptance criteria described.

Table 5-4: Performance Summary

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5.11 Conclusion

The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) and BD
FACSCanto™ flow cytometer (4-3-3 configuration) demonstrate substantial.
equivalence to the predica

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”