BD FACSCANTO SYSTEM

K040725 · Becton Dickinson Immunocytometry Systems · GKZ · Sep 10, 2004 · Hematology

Device Facts

• Record ID: K040725
• Device Name: BD FACSCANTO SYSTEM
• Applicant: Becton Dickinson Immunocytometry Systems
• Product Code: GKZ · Hematology
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The BD FACSCanto System with BD FACSDiva software is intended for use as an In Vitro Diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse wash sample preparation method for flow cytometry.

Device Story

Flow cytometer system comprising cytometer, wet cart, and computer; acquires/analyzes lysed, washed whole blood samples. Fluidic, optic, and electronic subsystems measure light signals (size, shape, granularity, fluorescence) as particles pass through a glass cuvette. Digital electronics process signals; BD FACSDiva software facilitates instrument setup, data acquisition, and analysis. Used in clinical laboratories by trained personnel. Operator performs manual or automated sample introduction. Software enables gating for multicolor analysis and reporting of lymphocyte subset percentages. Output assists clinicians in immunophenotyping; provides quantitative data on cell populations.

Clinical Evidence

Bench testing only. Performance evaluated per NCCLS guidelines: EP9-A2 for accuracy and EP5-A for precision. Additional testing included system carryover and linearity per FDA guidance for Automated Differential Cell Counters. Results demonstrated comparable accuracy to the predicate, acceptable system precision, and acceptable carryover and linearity performance.

Technological Characteristics

Flow cytometer with digital electronics. Lasers: 488 nm solid state, 633 nm HeNe. Detectors: 1 FSC, 1 SSC, 6 fluorescence PMTs. Optics: fiber optics, prisms, lasers. Fluidics: external wet cart. Software: BD FACSDiva. Connectivity: computer-integrated. Sterilization: N/A.

Indications for Use

Indicated for immunophenotyping in clinical laboratories using cleared IVD flow cytometry assays with lyse wash preparation. Specifically for lymphocyte subsets: CD3+CD8+, CD3+CD4+, CD3-CD16+ and/or CD56+, CD3-CD19+, and CD3+.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• BD FACSCalibur with 4-color option (K973483)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K040725

B. Purpose for Submission:
New device

C. Manufacturer and Instrument Name:
Becton Dickinson Immunocytometry Systems
BD FACS Canto Flow Cytometer with BD FACS Diva Software

D. Type of Test or Tests performed:
Semi-quantitative, optical

E. System Descriptions:

1. Device Description:
The BD FACS Canto System is comprised of a flow cytometer, a wet cart, and a computer. The wet cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics and electronics. It contains one software package for manual immunophenotyping and is compatible with the BD FACS Loader for automatic sample introduction.

2. Principles of Operation:
The BD FACS Canto flow cytometer combines fluidic, optic, and electronic subsystems to measure and analyze signals emitted when particles flow in a liquid stream through a glass cuvette, at which beams of laser light are directed. The emitted light from these particles provides information about cell size, shape, granularity, and fluorescence intensity.

3. Modes of Operation:
Random access or automatic sampling, open tube

4. Specimen Identification:
Manual identification by operator or instrument automatic numbering

5. Specimen Sampling and Handling:
Lysed washed cell suspension from whole blood sample; open tube using manual or automated sample introduction.

6. Calibration:
Not provided.

7. Quality Control:
Instrument quality control is performed to ensure consistent instrument performance. Quality control parameters should be as constant as possible

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using the same particle (beads) type, lot number and flow rate from day to day. The BD FACS Diva software provides a template to use as a starting point for the QC experiment. The QC experiment contains a preformatted global worksheet. The worksheet contains the analysis objects (plots, gates, statistics) needed to perform QC.

8. Software:
BD FACSDiva software can be used to facilitate instrument setup, communicate between the cytometer and the computer, and acquire and analyze data. The software allows the setting of gates for multicolor data analysis, and to report lymphocyte subset percentage.

FDA has reviewed the applicant’s Hazard Analysis and software Documentation: Yes ☑ or No ☐

F. Regulatory Information:

1. Regulation Section: 21 CFR 864.5220, Automated differential cell counter
2. Classification: Class II
3. Product Code: GKZ, Counter, differential cell
4. Panel: Hematology (81)

G. Intended Use:

1. Indication(s) for Use:
BD FACS Canto Flow Cytometer with BD FACS Diva Software is used for immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method. The lymphocytes subsets include; CD3⁺CD8⁺, CD3⁺CD4⁺, CD3⁻ CD16⁺ and/or CD56⁺, CD3⁻CD19⁺, and CD3⁺.
2. Special Condition for use Statement(s):
Not applicable.

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:
BD FACSCalibur, K973483
2. Comparison with Predicate Device:

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| Item | Device | Predicate |
| --- | --- | --- |
| | BD FACS Canto Flow Cytometer with FACS Diva Software | BD FACSCalibur with FACSComp Software |
| Intended Use | For use as an in-vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse wash sample preparation method for flow cytometry. | Same |
| Lasers | Blue – 488 nm solid state
Red – 633 nm HeNe | Blue – 488 nm argon ion
Red – 635 nm diode laser |
| Software | BD FACSDiva version 4.0 | BD Simulset™ |
| Differences | | |
| Item | Device | Predicate |
| | | |
| Detectors | 1 FSC photodiode
1 SSC photomultiplier tube
4 fluorescence detector PMTs
plus 2 additional fluorescence detector PMTs | Same FSC
Same SSC
4 fluorescence detector PMTs |
| Optics | Laser light delivered by fiber optics, prisms and lasers
Emitted light delivered by collection an fiber optics | Laser light delivered by mirrors, prisms and lenses
Emitted light delivered by mirrors |
| Electronics | Digital | Analog |
| Fluidics | Addition of an external wet cart to supply bulk fluids and hold waste. | BD FACS Flow sheath fluid cubitainer |

I. Standard/Guidance Document Referenced (if applicable):
EP9-A2 Method Comparison and Bias Estimation Using Patient Samples, Approved Standard-Second Edition, NCCLS
EP5A Evaluation of Precision Performance of Clinical Chemistry Device Approved Guideline, NCCLS
Class II Special Controls Guidance Document: Premarket Notification for Automated Differential Cell Counters for immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.
EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures, Approved Guideline, NCCLS
ICSH Expert Panel on Cytometry, Guidelines for Evaluation of Blood Analyzers, Cytometry Clinical Laboratory Haematolog, 1994, 16, 157-

J. Performance Characteristics:

1. Analytical Performance:
a. Accuracy:
A comparison study was performed using 128 samples from both normal and abnormal donors from three donor sites. The reported

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subset percentages were compared to the predicate device. See linear regression results below:

| Measurement | Unit | CD3 | CD4 | CD8 | CD19 | CD16+56 |
| --- | --- | --- | --- | --- | --- | --- |
| Number | | 128 | 128 | 128 | 128 | 128 |
| Slope | | 0.99 | 1.03 | 0.98 | 1.01 | 0.96 |
| Confidence Interval | | 0.96,1.02 | 1.01,1.05 | 0.96,1.00 | 0.97,1.06 | 0.93,0.98 |
| Intercept | % | 1.9 | -0.50 | -99 | -0.20 | -0.85 |
| Confidence Interval | | -0.31, 4.11 | -0.03, 0.02 | -2.07,0.09 | -0.83,0.44 | -1.28,0.41 |
| Correlation Coefficient | % | 0.986 | 0.995 | 0.993 | 0.968 | 0.988 |

b. Precision/Reproducibility:

Two levels of control cells were run on three BD FACS Canto instruments equipped with a BD FACS Loader by four different operators. Measurements were obtained from two separate runs per day over 20 days; each runs separated by a minimum of four hours.

Precision Summary

| Lymphocyte subset | Within-Run Precision (SD) | Within-Run CV | Total Precision (SD) | Total CV |
| --- | --- | --- | --- | --- |
| Unit | % | % | % | % |
| CD3 | 1.04 | 1.6 | 1.17 | 1.8 |
| CD4 | 0.92 | 2.8 | 0.99 | 3.0 |
| CD8 | 1.06 | 3.5 | 1.15 | 3.8 |
| CD19 | 0.82 | 4.9 | 0.89 | 5.3 |
| CD16+56 | 0.79 | 4.8 | 0.83 | 5.1 |

c. Linearity:

Linearity was tested using beads with different fluorescence intensities. Five to seven intensities were tested for each of the six detectors. Ten replications were measured on each of three instruments. A summary of the results are as follows:

| Detector | Reference intensity range | Conclusion |
| --- | --- | --- |
| FITC (FL1) | 600-330,000 MEFL | Acceptable |
| PE (FL2) | 400-300,000 MEPE | Acceptable |
| PerCP-Cy5.5 (FL3) | 1,900-1,115,000 MEPCY5 | Acceptable |
| APC (FL4) | 0.025-100 RFI | Acceptable |
| PE-Cy7 (FL5) | 0.098-100 RFI | Acceptable |
| APC-Cy7 (FL6) | 0.025-100 RFI | Acceptable |

d. Carryover:

A carryover study was performed. Percent carryover was estimated by introducing three consecutive abnormally high leucocyte prepared

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samples followed by three consecutive abnormally low leucocyte prepared samples, and calculating the percent difference. All data collected with and without the BD FACS Loader met acceptable criteria.

e. Interfering Substances:
Not provided

2. Other Supportive Instrument Performance Data Not Covered Above

K. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.