← Product Code [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ) · K041074

# BD FACSCANTO WITH BD FACSANTO SOFTWARE (K041074)

_Bd Biosciences · GKZ · Sep 17, 2004 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K041074

## Device Facts

- **Applicant:** Bd Biosciences
- **Product Code:** [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ.md)
- **Decision Date:** Sep 17, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5220
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-wash sample preparation method for flow cytometry.

## Device Story

Flow cytometer system comprising fluidics cart, cytometer, and PC; acquires and analyzes human cell suspensions. Utilizes fluidics, optics (lasers/fiber optics), and digital electronics to measure light scatter and fluorescence. Input: cell samples; Output: identification and enumeration of lymphocyte subsets. Used in clinical laboratories by trained personnel. Software provides manual and automatic immunophenotyping analysis. Results displayed/printed for clinician review to support diagnostic decisions regarding lymphocyte populations. Benefits include automated, standardized cell subset quantification.

## Clinical Evidence

Bench testing only. Accuracy, precision, and linearity studies performed per NCCLS documents EP9-A2, EP5-A, and EP6-A. Results demonstrated comparable accuracy to predicate and acceptable precision and linearity.

## Technological Characteristics

Flow cytometer with fluidics, optics, and digital electronics. Lasers: 488 nm solid state, 633 nm HeNe. Detectors: 1 FSC photodiode, 1 SSC PMT, 6 fluorescence PMTs. Light delivery via fiber optics, prisms, and lenses. PC-based platform. Digital signal processing. Compatible with automated sample loader.

## Regulatory 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 ([K973483](/device/K973483.md))

## Reference Devices

- FACS Loader ([K953302](/device/K953302.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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

A. 510(k) Number:
K041074

B. Purpose for Submission:
New device

C. Manufacturer and Instrument Name:
Becton Dickinson Immunocytometry Systems
BD FACS Canto Flow Cytometer with BD FACS Canto 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 two software packages, one for manual immunophenotyping and one for automatic 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 no-wash cell suspension prepared from whole blood sample; open tube using manual or automated sample introduction.

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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 using the same particle (beads) type, lot number and flow rate from day to day. When using BD FACS Canto software, a process control is added to a worklist, entered as "Control" in the sample name, and run as a typical sample. The control results are automatically exported to a spreadsheet file and the file is used to track results over time.

8. Software:
BD FACS Canto software combines instrument QC and setup, acquisition and analysis, and optional automated sample loading. Compensation settings are recalculated automatically during voltage adjustment. Auto-gating algorithms isolate populations of interest, but the software allows manual gating, if necessary. Internal quality control checks the validity of the results. The results are reported in percentage and absolute counts.

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 Canto Software is used for immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-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.

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# H. Substantial Equivalence Information:

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

|  Item | Device | Predicate  |
| --- | --- | --- |
|   | BD FACS Canto Flow Cytometer with BD FACS Canto 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 no-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 FACS Canto | BD Multiset™  |
|  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 Hematology, 1994, 16, 157

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## J. Performance Characteristics:

### 1. Analytical Performance:

#### a. Accuracy:

A comparison study was performed using 108 samples from both normal and abnormal donors from two donor sites. The reported subset percentages and absolute counts were compared to the predicate device. See linear regression results below:

**Subset percentage**

|  Measurement | Unit | CD3 | CD4 | CD8 | CD19 | CD16+56  |
| --- | --- | --- | --- | --- | --- | --- |
|  Number |  | 108 | 108 | 108 | 108 | 108  |
|  Slope |  | 1.00 | 0.99 | 1.00 | 0.99 | 1.0  |
|  Confidence Interval |  | 0.98,1.02 | 0.98,1.00 | 0.98,1.02 | 0.97,1.02 | 0.97, 1.02  |
|  Intercept | % | -0.17 | 0.26 | 0.27 | -0.05 | 0.39  |
|  Confidence Interval |  | -1.86, 1.52 | -0.06, 0.57 | -0.62, 1.16 | -0.41,0.31 | 0.01,0.78  |
|  Correlation Coefficient |  | 0.993 | 0.998 | 0.996 | 0.994 | 0.989  |

**Subset absolute counts**

|  Measurement | Unit | CD3 | CD4 | CD8 | CD19 | CD16+56  |
| --- | --- | --- | --- | --- | --- | --- |
|  Number |  | 108 | 108 | 108 | 108 | 108  |
|  Slope |  | 0.99 | 0.97 | 0.96 | 1.02 | 0.95  |
|  Confidence Interval |  | 0.96,1.02 | 0.97,0.99 | 0.93,1.00 | 1.00,1.05 | 0.92, 0.99  |
|  Intercept | Cells/μL | -6.27 | 10.8 | 24.6 | -7.93 | 10.8  |
|  Confidence Interval |  | -53.2,40.7 | -5.51,27.0 | -8.84,58.1 | -17.9,2.01 | 1.87,19.8  |
|  Correlation Coefficient |  | 0.987 | 0.991 | 0.983 | 0.990 | 0.981  |

#### b. Precision/Reproducibility:

Two levels of control cells were run on three BD FACS Canto instruments equipped with a BD FACS Loader by three different operators. Measurements were obtained from two separate runs per day over 20 days; each runs was separated by a minimum of four hours. BD FACS Canto Flow Cytometer with BD FACS Canto Software demonstrated acceptable within run and total precision according to the precision criteria for each subset listed below:

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|  Lymphocyte subset | Within-Run Precision Criteria (%) |   | Total Precision Criteria (%)  |   |
| --- | --- | --- | --- | --- |
|   | % | Absolute count | % | Absolute count  |
|  CD3 | <2.5 | <10 | <2.5 | <10  |
|  CD4 | <2.5 | <10 | <2.5 | <10  |
|  CD8 | <2.5 | <10 | <2.5 | <10  |
|  CD19 | <2.5 | <15 | <2.5 | <15  |
|  CD16+56 | <2.5 | <20 | <2.5 | <20  |

c. Linearity:
Linearity was tested using data for each lymphocyte subset collected from 21 samples; seven dilutions with three replicate each (using the BD Multitest IMK Kit). See absolute count results below:

|  Lymphocyte subset | Linearity Range (cells/μL) | R² (%)  |
| --- | --- | --- |
|  CD3 | 48-9627 | 99.98  |
|  CD4 | 29-5827 | 99.96  |
|  CD8 | 22-4076 | 99.95  |
|  CD19 | 5-1131 | 99.93  |
|  CD16+56 | 4-671 | 99.78  |

d. Carryover:
Not performed. Carryover studies presented for BD FACS Canto with BD FACS Diva software (K040725) provided acceptable results. BD FACS Canto software introduced no hardware changes or mechanical modifications to affect carryover.

e. Interfering Substances:
Not applicable

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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K041074](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K041074)

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