FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS

K961623 · Becton Dickinson Monoclonal Center · GKZ · Jun 7, 1996 · Hematology

Device Facts

• Record ID: K961623
• Device Name: FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
• Applicant: Becton Dickinson Monoclonal Center
• Product Code: GKZ · Hematology
• Decision Date: Jun 7, 1996
• 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.

Device Story

Device consists of a bead kit (unstained, FITC, PE, and PerCP beads) and FACSComp software; used on Becton Dickinson flow cytometers. Beads provide reference signals to calibrate instrument settings; software processes bead fluorescence data to adjust photomultiplier tube (PMT) voltages, set fluorescence compensation for spectral overlap, and verify separation of system noise from forward/side scatter. Used by laboratory technicians in clinical settings to ensure instrument sensitivity and performance prior to running diagnostic flow cytometry applications. Output allows standardized instrument configuration, ensuring consistent data acquisition for clinical immune disease monitoring.

Clinical Evidence

Bench testing only. Studies conducted at Becton Dickinson laboratories evaluated storage stability (8 months), post-dilution stability (1 hour), and reproducibility (within-instrument over 30 days and between-lot). Results demonstrated performance within the specifications of the predicate device.

Technological Characteristics

Kit includes unstained, FITC, PE, and PerCP-conjugated beads. System utilizes fluorescence-based calibration for flow cytometers. Software-driven automated adjustment of PMT voltages and compensation settings. Compatible with FACScan, FACSort, and FACSCalibur platforms.

Indications for Use

Indicated for use in setting up and monitoring the performance of Becton Dickinson flow cytometers (FACScan, FACSort, or FACSCalibur) to support clinical applications, including monitoring of immune diseases.

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 Beads with AutoCOMP (K925274)

Submission Summary (Full Text)

{0}

Attachment D
Summary of Safety & Effectiveness
JUN - 7 1996
K961623

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

Submitter: Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131-1807

Contact: Anna Longwell, Esq.
Director, Regulatory Affairs–Corporate
[phone]

Summary date: April 24, 1996

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

Name: CaliBRITE™ 3 Color and FACSComp™

Classification: Accessory to a Class II Device

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

CaliBRITE™ 3 Color and FACSComp™ is substantially equivalent to CaliBRITE™ Beads with AutoCOMP™ (K 925274), cleared to market in September, 1994.

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

Becton Dickinson CaliBRITE 3 Color and FACSComp are intended for use on the Becton Dickinson flow cytometers FACScan™ or FACSort™ or FACSCalibur™. FACSComp Software and CaliBRITE 3 Color Beads are used to optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp Software and CaliBRITE 3 Color Beads 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 three FL channels. FACSComp Software and CaliBRITE 3 Color Beads are 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. CaliBRITE 3 Color will be provided as a Kit, comprising unstained, FITC, PE and PerCP beads. CaliBRITE PerCP beads will also be provided as a separate product, to be used with CaliBRITE Kits having unstained FITC and PE beads only.

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

For flow cytometer set up and monitoring of instrument performance.

CaliBRITE 3 Color
1
4/24/96
142

{1}

# Indications for Use

The procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.

# Clinical Utility

Flow Cytometry has been found useful in monitoring some forms of immune disease.

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

CaliBRITE 3 Color with FACSComp is substantially equivalent to CaliBRITE Beads with AutoCOMP, (K925274). The product is composed of a bead kit with three components identical to that of the predicate, and one new bead, conjugated with PerCP, to check sensitivity of the FL3 channel.

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

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

Several studies were performed:

- Stability was measured
- Storage stability was determined to be 8 months under the conditions of use.
- Once diluted, the three-bead preparation is stable for 1 hour after dilution.

- Reproducibility was measured
- Within instrument over 30 days
- Between lot
- Reproducibility was found to be within that for 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.


Anna Longwell, Esq.
Director, Regulatory Affairs – Corporate

4/24/96

CaliBRITE 3 Color
2
4/24/96
143