BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

K062087 · Bd Biosciences · GKZ · Sep 14, 2006 · Hematology

Device Facts

• Record ID: K062087
• Device Name: BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
• Applicant: Bd Biosciences
• Product Code: GKZ · Hematology
• Decision Date: Sep 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The BD FACSCanto II system is intended for use as an in vitro diagnostic device for the identification and enumeration of lymphocyte subsets in human cells in suspension.

Device Story

The BD FACSCanto II is a flow cytometer system comprising a fluidics cart, flow cytometer, and computer workstation. It processes whole blood samples to identify and enumerate lymphocyte subsets. The system utilizes fluidics, optics (lasers/prisms), and electronics to acquire and analyze samples. It supports manual or automated sample introduction (via optional BD FACS Loader) and preparation (via optional BD FACS Sample Prep Assistant II). The computer workstation runs BD FACSCanto clinical software for automated immunophenotyping (lyse/no-wash) and BD FACSDiva software for manual immunophenotyping (lyse/wash). The system is operated by laboratory personnel in a clinical setting. Output is displayed and printed for clinical review, aiding in the identification and enumeration of lymphocyte subsets to support clinical decision-making.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate modifications.

Technological Characteristics

Flow cytometry system; modifications to fluidics, optics, and electronic subsystems; includes BD FACS Loader sample introduction system; software-controlled operation; design conforms to 21 CFR 820.30.

Indications for Use

Indicated for immunophenotyping in clinical laboratories using cleared in vitro diagnostic flow cytometry assays; 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.

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 FACSCanto system (K041074, K040725)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

## SEP 1 4 2006

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 _ KO 62087

## Submitter Information

| Submitter: | BD Biosciences<br>2350 Qume Drive<br>San Jose, CA 9513 |
|------------|--------------------------------------------------------|
|------------|--------------------------------------------------------|

- Contact: Carter Navarro Regulatory Affairs Specialist Tel .: [phone] Fax: [phone] carter [e-mail]
Summary Date: July 20, 2006

## Device Name / Classification

Name: BD FACSCanto II system Class II (21 CFR 864.5220) – Automated differential cell counter Classification:

### Substantially Equivalent / Predicate Device

The BD FACSCanto II system is substantially equivalent to the BD FACSCanto system with BD FACSCanto clinical software and BD FACSDiva software (premarket notifications K041074 and K040725).

{1}------------------------------------------------

### Device Description

The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation. The fluidics 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. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping of assays prepared using the lyse/no-wash method, and BD FACSDiva software for manual immunophenotyping of assays prepared using the lyse/wash method.

The BD FACSCanto II system can optionally be used with the BD FACS Loader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software, and with the BD FACS Sample Prep Assistant II for automatic sample preparation of assays utilizing the lyse/no-wash method.

The BD FACSCanto II system is a modification of the BD FACSCanto system, bearing the same intended use, indications for use, and operating principle as its predicate device. Modifications have been made to the fluidics, optics, and electronics subsystems. Changes were also made to the sample introduction system, the BD FACS Loader option, and to the two software applications. These changes have been made to enhance the system's usability.

#### Intended Use

The BD FACSCanto II system is intended for use as an in vitro diagnostic device for the identification and enumeration of lymphocyte subsets in human cells in suspension.

{2}------------------------------------------------

## Technological Characteristics

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

| Characteristic | BD FACSCanto system<br>(predicate) | BD FACSCanto II system<br>(new family member) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended use | In vitro diagnostic device for<br>identification and enumeration of<br>lymphocyte subsets in human cells<br>in suspension using the lyse/wash<br>and lyse/no-wash sample<br>preparation methods for flow<br>cytometry. | Same. |
| Device classification and<br>product code | Automated Differential Cell<br>Counter<br>21 CFR 864.5220<br>Product Code: GKZ | Same. |
| Lasers | Red - 488-nm argon ion<br>Blue - 635-nm diode | Same. |
| Optics | Laser light delivered by fiber optics<br>and prisms.<br>Emitted light delivered by<br>collection and fiber optics. | Same. |
| Electronics | Multiple electronics boards<br>containing acquisition electronics<br>components. | One consolidated acquisition<br>electronics board. |
| Maximum parameter<br>detection | Eight<br>(FSC, SSC, and six fluorophores). | Same. |
| Software | BD FACSCanto clinical software<br>v.1.0 or higher and<br>BD FACSDiva software v.4.0 or<br>higher. | BD FACSCanto clinical software<br>v.2.1 or higher and<br>BD FACSDiva software v.5.0.1 or<br>higher. |
| Instrument setup and<br>quality control | Automated setup using BD<br>FACSCanto clinical software and<br>BD FACS 7-color setup beads. | Same. |
| Sample introduction | Manual, or automated with the<br>optional BD FACS Loader. | Same. |
| Sample preparation | Manual pipetting for the lyse/wash<br>or lyse/no-wash methods, or<br>automated with the BD FACS<br>Sample Prep Assistant II for the<br>lyse/no-wash method. | Same. |
| Characteristic | BD FACSCanto system<br>(predicate) | BD FACSCanto II system<br>(new family member) |
| Sample type | Whole blood. | Same. |
| Accessories | Optional standalone barcode reader. | Same. |

{3}------------------------------------------------

## Performance Data

| Study | Study Design | Results |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method<br>Comparison | Based on Method Comparison and Bias<br>Estimation Using Patient Samples, CLSI<br>document EP9-A2. | The BD FACSCanto II system<br>demonstrated comparable accuracy<br>relative to the predicate when<br>running the BD Multitest IMK kit<br>and BD Multitest 6-color TBNK<br>assays. |
| Precision | Based on Evaluation of Precision<br>Performance of Clinical Chemistry Devices,<br>CLSI document EP5-A2. | The BD FACSCanto II system<br>demonstrated acceptable precision<br>when running the BD Multitest IMK<br>kit and BD Multitest 6-color TBNK<br>assays. |
| Linearity | Based on Evaluation of the Linearity of<br>Quantitative Measurement Approaches: A<br>Statistical Approach, CLSI document<br>EP6-A. | The BD FACSCanto II system<br>demonstrated acceptable linearity<br>when running the BD Multitest IMK<br>kit and BD Multitest 6-color TBNK<br>assays. |
| % Agreement | Based on User Protocol for Evaluation of<br>Qualitative Test Performance, CLSI EP12- A. | The BD FACSCanto II system<br>demonstrated acceptable %<br>agreement when running the BD<br>HLA-B27 assay. |
| Reproducibility | Pairs (positive & negative) of specimens were<br>tested in duplicate by multiple operators,<br>twice daily for multiple operating days across<br>different instruments. | The BD FACSCanto II system<br>demonstrated acceptable<br>reproducibility when running the BD<br>HLA-B27 assay. |
| Carryover | Based on recommendations contained in Class<br>II Special Controls Guidance Document:<br>Premarket Notifications for Immature or<br>Abnormal Blood Cells; Final Guidance for<br>Industry and FDA, December 4, 2001. | The BD FACSCanto II system<br>demonstrated acceptable carryover. |

:

{4}------------------------------------------------

# Conclusions from Performance Data

:

. . . . .

The BD FACSCanto II system demonstrates substantial equivalence to the predicate device.

100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

.

:

:

{5}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### SEP I 4 2006

BD Biosciences Immunocytometry Systems 2350 Oume Dr. San Jose, CA 95131 ATTN: Carter Navarro

Re: k062087

Trade/Device Name: BD FACSCanto II flow cytometer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: July 20, 2006 Received: July 24, 2006

Dear Mr. Navarro:

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.

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

{6}------------------------------------------------

Page 2 –

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.

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. Rockey

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

Enclosure

{7}------------------------------------------------

## Indications for Use

510(k) Number: K062087
(if known)

Device Name: BD FACSCanto II System

#### Indications for Use:

- 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. .

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE OF NEEDED

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|-------------------------------------------------------------------|--|
|-------------------------------------------------------------------|--|

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K062087
al 510(k) Device Modification Notification

BD Biosciences Special 510(k) Device Modification Notifica
BD FACSCanto II System
07/20/2006

Page 1 of

Section Page 6 of 19