MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS

K963963 · Becton Dickinson Immunocytometry Systems · GKZ · Dec 12, 1996 · Hematology

Device Facts

• Record ID: K963963
• Device Name: MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
• Applicant: Becton Dickinson Immunocytometry Systems
• Product Code: GKZ · Hematology
• Decision Date: Dec 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MultiSET is an accessory software to in vitro diagnostic reagents employing CD45 gating for identification and enumeration of lymphocyte subsets in human peripheral blood.

Device Story

MultiSET software; accessory to flow cytometry reagents; processes three-color direct immunofluorescence data from erythrocyte-lysed whole blood samples. Input: flow cytometric data using CD45 gating. Operation: automates determination of analysis gates to identify lymphocyte populations based on CD45+ leucocytes with low side scatter. Output: percentages of lymphocyte subsets. Used in clinical laboratories; operated by technicians/clinicians. Benefit: automates manual gating process; provides consistent enumeration of lymphocyte subsets for monitoring immunodeficiency and autoimmune conditions.

Clinical Evidence

Bench testing comparing automated MultiSET to manual CELLQuest. Sample size: 41 donors (17 normal, 24 abnormal). Primary endpoint: accuracy of lymphocyte subset enumeration. Results: MultiSET provided equivalent performance to manual predicate software.

Technological Characteristics

Software accessory for flow cytometry; utilizes CD45 gating for immunophenotyping; automated gate determination algorithm; operates on flow cytometer workstation.

Indications for Use

Indicated for identification and enumeration of lymphocyte subsets in human peripheral blood for monitoring immunodeficiency and autoimmune disease.

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

• CELLQuest (K946055)

Submission Summary (Full Text)

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# Attachment E
## Summary of Safety and Effectiveness

K963963

**Submitter Information (21 CFR 807.92(a)(1))**
*Submitter: Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131-1807
DEC 12 1996

**Contact:** Cindy Morrow
Senior Regulatory Specialist
[phone]

**Summary date:** September 30, 1996

**Name of Device and Classification (21 CFR 807.92(a)(2))**
**Name:** MultiSET™ software
**Classification:** Class II

**Predicate Device (21 CFR 807.92(a)(3))**
MultiSET software for automated flow cytometric analysis of TriTEST reagents is substantially equivalent to the predicate software, CELLQuest™, which was described in 510(k) K946055.

**Description of the Device (21 CFR 807.92(a)(4))**
Becton Dickinson MultiSET software is a three-color, direct immunofluorescence method for identifying and enumerating percentages of lymphocyte subsets in erythrocyte-lysed whole blood. The software is an accessory to reagent products which use CD45 gating for immunophenotyping by flow cytometry.

Both the manual CELLQuest software and the automated MultiSET software rely on a lymphocyte gate drawn for the CD45⁺ leucocytes with low side scatter. Lymphocyte subsets as a percent of total lymphocytes are then identified as a proportion of events included in the lymphocyte gate.

**Intended Use (21 CFR 807.92(a)(5))**
MultiSET is an accessory software to in vitro diagnostic reagents employing CD45 gating for identification and enumeration of lymphocyte subsets in human peripheral blood.

**Clinical Utility**
The determination of lymphocyte subsets have been found useful in monitoring some forms of immunodeficiency and autoimmune disease.

MultiSET 510(k) Notification
9/30/96 156

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MultiSET 510(k) Notification
157
9/30/96

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

The MultiSET automated software is substantially equivalent to the CELLQuest software in that they share the same intended uses and similar methodologies. Results demonstrate that the products yield essentially equivalent performance. The products differ in that MultiSET software automates the steps used to determine analysis gates to identify the lymphocyte populations.

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

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

Accuracy was determined by comparison of results from the automated MultiSET software with results from the predicate manual software. Lysed whole blood samples from 41 donors, including 17 normals and 24 abnormals, were analyzed by the automated and manual softwares. Accuracy data demonstrated that MultiSET software provides equivalent results to the manual CELLQuest software.

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

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