(269 days)
No
The summary describes a standard flow cytometer system with dedicated clinical software for cell identification and enumeration, and explicitly states that mentions of AI, DNN, or ML were "Not Found".
No
This device is an in vitro diagnostic (IVD) device used for identifying and enumerating human cell subsets, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use with cleared or approved in vitro diagnostic (IVD) assays" for "identification and enumeration of human cell subsets" and is "For in vitro diagnostic use." This directly classifies it as a diagnostic device.
No
The device description explicitly states that the system is comprised of a flow cytometer, a fluidics cart, and a computer workstation, indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Function as part of a system with IVD assays: The text describes the device as functioning "as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays." This indicates its role in a diagnostic workflow.
- Identification and enumeration of human cell subsets: The intended use is for identifying and enumerating human cell subsets, which is a common application in clinical diagnostics.
- Cleared for in vitro diagnostic use: Specific detection channels are explicitly stated as being "cleared for in vitro diagnostic use."
N/A
Intended Use / Indications for Use
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 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.
BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) with BD FACSCanto™ clinical software and BD FACSDiva™ 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OYE
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cell subsets
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy/Method Comparison
Study Design: Based on Method Comparison and Bias Estimation Using Patient Samples, CLSI document EP9-A2.
Results: 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 MultitestTM IMK Kit (4-color) and BD MultitestTM 6-color TBNK (with TrucountTM) assays.
Precision
Study Design: Based on Evaluation of Precision Performance of Clinical Chemistry Devices, CLSI document EP5-A2.
Results: 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
Study Design: Based on Evaluation of the Linearity of Quantitative Measurement Approaches: A Statistical Approach, CLSI document EP6-A.
Results: 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
Study Design: Three samples with a high White Blood Cell concentration were acquired, followed by three low WBC concentration samples. Carryover Calculation: $100% * [ (L1-L3) / (H3-L3) ]$
Results: The mean carryover measured from manual acquisition and the mean carryover from Loader acquisition both met the acceptance criteria described.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
1
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
2
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)
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.
| 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."
3
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)
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.
| 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."
4
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.
5
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 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.
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
6
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 and |
| Parameter/Fluorochrome |
| Model | Lasers | Optics and
Parameter/Fluorochrome
Detection |
|-------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------|
| BD FACSCanto II 4-2
(reference device) | 488-nm (blue)
633-nm (red) | 7 photomultiplier tubes
Parameter detection: FSC, SSC, six
fluorochromes |
| BD FACSCanto II 5-3 | 488-nm (blue)
633-nm (red) | 9 photomultiplier tubes
Parameter detection: FSC, SSC,
eight fluorochromes |
| BD FACSCanto II 4-2-2 | 405-nm (violet)
488-nm (blue)
633-nm (red) | 9 photomultiplier tubes
Parameter detection: FSC, SSC,
eight fluorochromes |
Table 5-2: Instrument Configurations of BD FACSCanto
| Model | Lasers | Optics and
Parameter/Fluorochrome
Detection |
|-----------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------|
| BD FACSCanto 4-2
(predicate device) | 488-nm (blue)
633-nm (red) | 7 photomultiplier tubes
Parameter detection: FSC, SSC, six
fluorochromes |
| BD FACSCanto 4-3-3 | 405-nm (violet)
488-nm (blue)
640-nm (red) | 11 photomultiplier tubes
Parameter detection: FSC, SSC, ten
fluorochromes |
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.
7
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.
8
| 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 as
in vitro diagnostic devices for
the identification and
enumeration of lymphocyte
subsets in human cells in
suspension.
Immunophenotyping in
clinical laboratories,
using previously cleared
in vitro diagnostic assays
for flow cytometry. Identification and
enumeration of
lymphocyte subsets in
human cells in
suspension. For in vitro diagnostic
use. For use with or without
the BD FACS Sample
Prep Assistant II. | The BD FACSCanto II
(4-2) system is intended
for use as in vitro
diagnostic devices for the
identification and
enumeration of
lymphocyte subsets in
human cells in
suspension.
Immunophenotyping
in clinical
laboratories, using
previously cleared in
vitro diagnostic
assays for flow
cytometry. Identification and
enumeration of
lymphocyte subsets
in human cells in
suspension. For in vitro
diagnostic use. For use with or
without the BD
FACS Sample Prep
Assistant III | 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 Sample Prep
Assistant III.
For in vitro diagnostic
use. | Same as BD
FACSCanto II (5-3) | 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. |
| Device Classification
and Product Code | Automated Differential Cell
Counter 21 CDR 864.5220
Product 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 laser
488nm solid state, 20mW | Blue laser
Same | Blue laser
Same | Blue laser
Same | Blue laser
Same |
| | Red laser
633nm HeNe, 17mW | Red laser
Same | Red laser
Same | Red laser
Same | Red laser
640nm solid state, 40mW |
| IVD Optical Detection | 1st detector array
Blue “octagon” receives
488nm-excited and scattered
light. The array is configured
to detect SSC and 4
fluorochromes (FITC, PE,
PerCP/PerCP-Cy5.5, PE-Cy7) | 1st detector array
modified to enable
additional detectors in 5-3
configuration | 1st detector array same
as BD FACSCanto II 4-2
configuration but an
additional detector is
enabled | 1st detector array
same as BD
FACSCanto II 4-2
configuration | 1st detector array
similar to BD FACSCanto
4-2 configuration with
minor filter modification. |
| | 2nd detector array
Red “trigon” receives 633nm-
excited light. The array is
configured to detect 2
fluorochromes (APC, APC-
Cy7) | 2nd detector array
modified to enable
additional detectors in 5-3
configuration | 2nd detector array
same as BD FACSCanto
II 4-2 configuration but
an additional detector is
enabled | 2nd detector array
same as BD
FACSCanto II 4-2
configuration | 2nd detector array
similar to BD FACSCanto
II 4-2 configuration, with
minor filter modification.
An additional detector is
enabled. |
| Electronics | Electronics boards containing
acquisition electronics
components | Electronics board with
improved preamplifier
circuitry. | Same as BD FACSCanto
II 4-2 configuration. | Same as BD
FACSCanto II 4-2
configuration. | Similar to BD
FACSCanto 4-2 with
modifications 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 valve
assembly which controls the
flow of sample, saline, and
waste fluids. Includes a
separate wet cart assembly. | Consists of a block that
duplicates FACSCanto
fluidic scheme. Use of
manifold improves
reliability and ease of
serviceability. | Same as BD FACSCanto
II 4-2 configuration. | Same as BD
FACSCanto II 4-2
configuration. | Same as BD FACSCanto
II 4-2 configuration. |
| Fluidics Cart | Original FACSCanto design
with FACSFlow™ sheath
fluid cubitainer | BD FACSCanto fluidics
cart with the
incorporation of a
manifold assembly and
improved chemical
compatibility of valve
material. | Same as BD FACSCanto
II 4-2 configuration. | Same as BD
FACSCanto II 4-2
configuration. | Same as BD FACSCanto
II 4-2 configuration. |
| Sample Introduction | Original FACSCanto Sample
injection tube (SIT) design | SIT with modified tube
guide, sensor, and probe
tip | Same as BD FACSCanto
II 4-2 configuration. | Same as BD
FACSCanto II 4-2
configuration. | Same as BD FACSCanto
4-2 |
| Automated Sample
Presentation | BD FACSLoader | BD FACSLoader with
updated motor, pneumatic
actuation, and sliding
access doors | Same as BD FACSCanto
II 4-2 configuration. | Same as BD
FACSCanto II 4-2
configuration. | Same as BD FACSCanto
4-2 |
| Software | BD FACSCanto clinical
software v1.0 or higher
BD FACSDiva software v4.0
or higher | BD FACSCanto clinical
software v2.1 or higher
(currently v3.0)
BD FACSDiva software
v5.0.1 or higher | Same as BD FACSCanto
II 4-2 configuration
(currently v3.0). | Same as BD
FACSCanto II 4-2
configuration
(currently v3.0). | BD FACSCanto clinical
software v2.4 or higher
(currently v3.0)
BD FACSDiva software
v7.0 or higher. |
| Instrument Setup and
Quality Control | Automated setup using BD
FACSCanto clinical software
and BD FACS 7-color setup
beads | Same | Same | Same | Same |
| Sample Preparation | Manual pipetting for the
lyse/wash or lyse/no-wash
methods, or automated with
the BD FACS Sample Prep
Assistant (SPA) for the
lyse/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/Method | ||
| Comparison | Based on Method Comparison and | |
| Bias Estimation Using Patient | ||
| Samples, CLSI document EP9-A2. | 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 MultitestTM IMK Kit (4- | ||
| color) and BD MultitestTM 6-color | ||
| TBNK (with TrucountTM) assays. | ||
| Precision | Based on Evaluation of Precision | |
| Performance of Clinical Chemistry | ||
| Devices, CLSI document EP5-A2. | 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 | Based on Evaluation of the | |
| Linearity of Quantitative | ||
| Measurement Approaches: A | ||
| Statistical Approach, CLSI | ||
| document EP6-A. | 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 | Three samples with a high White | |
| Blood Cell concentration were | ||
| acquired, followed by three low | ||
| WBC concentration samples. | ||
| Carryover Calculation: | ||
| $100% * [ (L1-L3) / (H3-L3) ]$ | The mean carryover measured from | |
| manual acquisition and the mean | ||
| carryover from Loader acquisition both | ||
| met 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