BD FACSCANTO WITH BD FACSANTO SOFTWARE

K041074 · Bd Biosciences · GKZ · Sep 17, 2004 · Hematology

Device Facts

• Record ID: K041074
• Device Name: BD FACSCANTO WITH BD FACSANTO SOFTWARE
• Applicant: Bd Biosciences
• Product Code: GKZ · Hematology
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for immunophenotyping of lymphocyte subsets (CD3, CD4, CD8, CD19, CD16/56) in clinical laboratories using lyse no-wash IVD assays.

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 (K973483)

Reference Devices

• FACS Loader (K953302)

Submission Summary (Full Text)

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#### 1 2004 OCT

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kim Fonda Senior Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, California 95131

> k041074 Trade/Device Name: BD FACSCanto System with BD FACSCanto software Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 11, 2004 Received: August 13, 2004

Dear Ms. Fonda:

Re:

This letter corrects our signed letter of September 17, 2004, regarding the typo to the device name. 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 (OS) 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, h

Robert L. Becker, Jr., M.D., Ph. 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 D 510(k) Summary

# BD FACSCanto with BD FACSCanto 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 K041074.

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

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

- Kim Fonda Contact: Sr. Regulatory Affairs Specialist 、 [phone] [phone] (FAX) [e-mail]
Summary date: April 22, 2004

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

BD FACSCanto™ System with BD FACSCanto 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 FACSCanto software is substantially equivalent to the BD FACSCalibur™ with 4-color option for immunophenotyping using BD Multitest reagents and BD Multiset software. The BD 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 with BD FACSCanto 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 FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. The fluidics cart contains operational fluids, the

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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 two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.

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

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.

# 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<br>(new family member) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For identification and enumeration of<br>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 no-<br>wash sample preparation<br>method for flow cytometry |
| Device<br>classification and<br>product code | Automated Differential Cell Counter, 21<br>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<br>Laser light delivered by mirrors, prisms<br>and lenses<br>Emitted light delivered by mirrors | Same<br>Laser light delivered by fiber<br>optics, prisms and lasers<br>Emitted light delivered by<br>collection and fiber optics |

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:

| Characteristic | FACSCalibur System<br>(predicate) | BD FACSCanto System<br>(new family member) |
|----------------------------------|-------------------------------------|--------------------------------------------|
| Electronics | Analog | Digital |
| Automated sample<br>introduction | FACS Loader:<br>K953302<br>11/20/95 | Same |
| 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 with BD FACSCanto<br>software demonstrated comparable<br>accuracy relative to the predicate. |
| Precision | Based on NCCLS document, EP5-A.<br>(February 1999) | The BD FACSCanto with BD FACSCanto<br>software demonstrated acceptable system<br>precision. |
| Linearity | Based on NCCLS document, EP6-A.<br>(April 2003) | The BD FACSCanto with BD FACSCanto<br>software demonstrated acceptable system<br>linearity. |

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

The BD FACSCanto System demonstrates substantial equivalence to the predicate device.

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Attachment G Indications for Use Statement

# Indications for Use

# 510(k) Number: K041074

Device Name: BD FACSCanto System with BD FACSCanto software

# Indications for Use:

- s Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method.
- Immunophenotyping of lymphocyte subsets including CD3*CD8*, . CD3*CD4*, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*

# Clinical Significance:

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Diagnostic DeviceOffice of In Vitro Diagnostic Device Office tion and Safety

510(k) K041074

Becton Dickinson Immunocytometry Systems 510(k) Notification BD FACSCanto System with BD FACSCanto software 4/22/04 Replacement Page 9/7/04

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