FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET

K973483 · Becton Dickinson Immunocytometry Systems · GKZ · Feb 17, 1998 · Hematology

Device Facts

• Record ID: K973483
• Device Name: FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
• Applicant: Becton Dickinson Immunocytometry Systems
• Product Code: GKZ · Hematology
• Decision Date: Feb 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease.

Device Story

CaliBRITE APC beads and FACSComp software function as an accessory for Becton Dickinson flow cytometers (FACSort/FACSCalibur) equipped with an FL4 option. The system uses fluorescently labeled polystyrene beads to calibrate instrument performance. Operators use the beads to check laser alignment, set PMT voltages, and establish fluorescence compensation to correct for spectral overlap. The software automates these setup procedures, allowing the clinician to verify the separation of system noise from forward/side scatter signals. By ensuring optimal instrument settings and sensitivity, the device enables accurate downstream clinical applications, such as immunophenotyping and reticulocyte enumeration, which assist in monitoring immune diseases. The system is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Studies evaluated bead stability (8 months storage; 8 hours for 2-bead preparation; 1 hour for 5-bead preparation) and reproducibility. Reproducibility was assessed across bead lots, instrument platforms, setup options (lyse/wash vs. lyse/no-wash), and over a 20-day period. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Consists of polystyrene beads conjugated with FITC, PE, PerCP, and APC fluorescent dyes. System utilizes flow cytometry sensing principles to measure fluorescence and light scatter. Software-driven automated setup for PMT voltage, laser alignment, and compensation. Designed for use with Becton Dickinson FACSort and FACSCalibur flow cytometers.

Indications for Use

Indicated for use with FACS family flow cytometers (FACScan, FACSort, FACSCalibur) as an accessory for instrument setup, alignment of blue/red lasers, PMT voltage adjustment, performance monitoring, automated fluorescence compensation, and sensitivity verification prior to reticulocyte enumeration or immunophenotyping.

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

• CaliBRITE 3 kit and FACSCOMP software (K961623)

Submission Summary (Full Text)

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K973483

### Attachment G

FEB 1 7 1998

### 510(k) Summary

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

| Submitter: | Becton Dickinson Immunocytometry System<br>2350 Qume Drive<br>San Jose, CA 95131-1807 |
|------------|---------------------------------------------------------------------------------------|
| Contact: | Cindy Morrow<br>Sr. Regulatory Specialist |

Summary date: December 17, 1997

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

[phone]

| Name: | CaliBRITE™ APC beads, CaliBRITE 4 kit (unlabeled, FITC-, PE-, PerCP- and APC labeled CaliBRITE beads), and FACSComp™ software |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Accessory to a Class II Device |

### Predicate Device (21 CFR 807.92(a)(3))

CaliBRITE™ 4 kit and FACSComp™ software is substantially equivalent to CaliBRITE™ 3 kit (unlabeled, FITC-, PE-, and PerCP-labeled CaliBRITE beads) and FACSCOMP™ software, K961623, cleared to market on June 7, 1996.

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

Becton Dickinson FACSComp software and the CaliBRITE 4 bead kir (FACSComp/CaliBRITE 4) are intended for use on the Becton Dickinson flow cytometers, FACSort™ or FACSCalibur™, equipped with the FL4 Option. FACSComp/CaliBRITE 4 are used to check laser alignment, optimally adjust instrument settings, monitor sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp/CaliBRITE 4 are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with four fluorescence (FL) channels FACSComp/CaliBRITE 4 is used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on flow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. The CaliBRITE beads are provided as a separate vial of CaliBRITE APC beads and the four-vial CaliBRITE 3 kit, comprised of unstained, FITC-, PE- and PerCP-labeled beads.

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

For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease.

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## Comparison to Predicate Device (21 CFR 807.92(a)(6))

FACSComp/CaliBRITE 4 is substantially equivalent to FACSComp software and the CaliBRITE 3 kit, (K961623). The product is composed of four vials of beads that are identical to that of the predicate, and the new CaliBRITE APC vial, containing polystyrene beads conjugated with APC that are used to set up the FL4 Option.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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

Performance of this product was established by testing at Becton Dickinson Immunocytomerry Systems laboratories in San Jose, California.

Several studies were performed:

- · Stability was measured
1-

Storage stability of beads was determined to be 8 months under the conditions of use.

Once diluted, the two-bead preparation of CaliBRITE APC and unlabeled beads (Tube A) is stable for 8 hours. The five-bead preparation (Tube B) is stable for 1 hour after dilution.

#### · Reproducibility was measured

Berween bead lots.

Within instrument across two computer platforms.

Within the set up options of lyse and wash (L/W) and lyse no wash (LNW) across colors.

Between manual and automated 4-color LNW setup options.

Within instrument over 20 days.

Reproducibility was found to be equivalent to the predicate device.

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

The results of the design verification studies demonstrate that the device is as safe and effective as the predicate device.

Clint Morris

Cindy Morrow. Sr Regulatory Specialist

12/17/97

Date

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads facing to the right, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the figure. The figure is black, and the text is also black.

Food and Drug Administration Cindy Morrow 2098 Gaither Road Sr. Regulatory Specialist Rockville MD 20850 Becton Dickinson Immunocytometry Systems FEB 1 7 1998 2350 Oume Drive San Jose, California 95131-9475 K973483 Re: Trade Name: Becton Dickinson Immunocytometry Systems (BDIS) CaliBRITE™ APC (Allophycocyanin) beads, CaliBRITE 4 kit (unlabeled, FITC, PE, PerCP, and APC labeled CaliBRITE beads), and FACSComp™ software. Regulatory Class: II Product Code: GKZ December 17, 1997 Dated: Received: December 18, 1997

Dear Ms. Morrow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

1. . . . .

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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| 510(k) Number (if known): | K973483 |
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Device Name:

Indications For Use:

Attachment A-Indications for Use:

For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).

An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.

For adjusting instrument settings: aligning the signal from the blue and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time.

For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.

For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals.

For in vitro diagnostic use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)