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

Intended 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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Attachment D 510(k) Summary

## BD FACSCanto System with BD FACSDiva software 510(k) Summary

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

The assigned 510(k) number is K040725.

#### Submitter Information (21 CFR 807.92(a)(1))

Becton Dickinson Immunocytometry Systems Submitter: 2350 Qume Drive San Jose, CA 95131

- Contact: Kim Fonda Sr. Regulatory Affairs Specialist [phone] [phone] (FAX) kim fonda(@)bd.com
March 19, 2004 Summary date:

#### Device Name and Classification (21 CFR 807.92(a)(2))

BD FACSCanto™ System with BD FACSDiva™ software Name: Classification: Class II (21 CFR 864.5220), Automated differential cell counter

### Substantially Equivalent / Predicate Device (21 CFR 807.92(a)(3))

The BD FACSCanto System with BD FACSDiva software is substantially equivalent to the BD FACSCalibur™ with 4-color option for immunophenotyping using SimulTEST reagents and associated software. FACSCalibur 4-color instrument was cleared with FACSComp Software and CaliBRITE Beads by the Center for Devices and Radiological Health, under K973483 on 2/17/98. The BD FACSCanto System with BD FACSDiva software and BD FACSCalibur have similar intended uses, measure the same sample types and have similar performance characteristics.

#### Device Description (21 CFR 807.92(a)(4))

The BD FACSCanto System with BD FACSDiva software 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 sub-systems; fluidics, optics and electronics. It contains one software package for

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manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.

# Intended Use (21 CFR 807.92(a)(5))

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.

# Technological Characteristics (21 CFR 807.92(a)(6))

The following summary table describes the similarities and differences between the BD FACSCanto and the BD FACSCalibur.

| Characteristic | FACSCalibur System<br>(predicate) | BD FACSCanto System with<br>BD FACSDiva software<br>(new family member) |
|----------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For identification and enumeration<br>of leucocyte subsets in human cells in<br>suspension | For identification and<br>enumeration of lymphocyte<br>subsets in human cells in<br>suspension using a lyse wash<br>sample preparation method for<br>flow cytometry. |
| Device<br>classification and<br>product code | Automated Differential Cell Counter<br>21 CFR 864.5220<br>Product Code: GKZ | Same |
| Lasers | Blue—488 nm argon ion<br>Red—635 nm diode laser | 488 nm solid state<br>633 nm HeNe |
| Detectors | 1 FSC photodiode<br>1 SSC photomultiplier tube (PMT)<br>4 fluorescence detector PMTs | Same FSC<br>Same SSC<br>Same 4 plus 2 additional<br>fluorescence detector PMTs |
| Optics | FACSCalibur flow cell | Same |
| | Laser light delivered by mirrors, prisms<br>and lenses<br>Emitted light delivered by mirrors | Laser light delivered by fiber<br>optics, prisms and lasers<br>Emitted light delivered by<br>collection and fiber optics |
| Electronics | Analog | Digital |
| Automated sample<br>introduction | FACS Loader:<br>K953302, 11/20/95 | Same |

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| Characteristic | FACSCalibur System<br>(predicate) | BD FACSCanto System with<br>BD FACSDiva software<br>(new family member) |
|-------------------|-----------------------------------|-------------------------------------------------------------------------|
| Computer platform | Macintosh | PC |

## Performance Data (21 CFR 807.92(b)(1)and (2))

| Study | Study Design | Results |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Accuracy | Based on NCCLS document EP9-A2.<br>(September 2002) | The BD FACSCanto demonstrated<br>comparable accuracy relative to the<br>predicate. |
| Precision | Based on NCCLS document EP5-A.<br>(February 1999) | The BD FACSCanto demonstrated<br>acceptable system precision. |
| Carryover | Based on recommendations contained in<br>"Class II Special Controls Guidance<br>Document: Premarket Notifications for<br>Automated Differential Cell Counters for<br>Immature or Abnormal Blood Cells; Final<br>Guidance for Industry and FDA."<br>(December 4, 2001) | The BD FACSCanto demonstrated<br>acceptable system carryover. |
| Linearity | Based on recommendations contained in<br>"Class II Special Controls Guidance<br>Document: Premarket Notifications for<br>Automated Differential Cell Counters for<br>Immature or Abnormal Blood Cells; Final<br>Guidance for Industry and FDA."<br>(December 4, 2001) | The BD FACSCanto demonstrated<br>acceptable system linearity. |

# Conclusions from Performance Data (21 CFR 807.92(b)(3))

.

The BD FACSCanto System with BD FACSDiva software demonstrates substantial equivalence

to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kim Fonda Sr. Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive

SEP 1 0 2004

San Jose, CA 95131

SEP 10 2004

k040725 Re: Trade/Device Name: BD FACSCanto System with BD FACSDiva software Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 4, 2004 Received: August 6, 2004

Dear Ms. Fonda

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 r ou mayy attols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment G Indications for Use Statement

#### Indications for Use

#### 510(k) Number: K040725

Device Name: BD FACSCanto System with BD FACSDiva software

# Indications for Use:

- . Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.
- . Immunophenotyping of lymphocyte subsets including CD3*CD8*, CD3 *CD4*, CD3 CD16* and/or CD56*, CD3 -CD19*, and CD3*.

### Clinical Significance:

- I For In Vitro Diagnostic Use.
Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use -AND/OR (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Division Sign-Off**

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040725

Becton Dickinson Immunocytometry Systems 510(k) Notification BD FACSCanto System 3/19/04 Replacement Page 9/7/04