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CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-PC5, is used to monitor nonspecific staining.

CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluoresent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.

CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocvte levels following organ transplantation.

To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or progrosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (induce) and CD8+ (suppressor/cytoxic) T lymphocytes and corresponding T478 ratios, may aid in the diagnois and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.

NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.

As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-.

CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies conjugated to RD1 and PC5.

This document describes the safety and effectiveness information for the NOV COULTER CORPORATION's CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with its corresponding Isotypic Control. The information provided focuses on the product's performance specifications and how it meets them.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "performance specifications" that the device is stated to meet. The study's results demonstrated that the device successfully met these specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years." However, the exact number of specimens/samples used for the accuracy, linearity, and precision studies is not explicitly stated. For the within-run precision, "Ten replicate measurements were made for each of three levels of CD3+ and CD3-/CD56+ lymphocyte concentrations." For interlaboratory precision, "Ten replicate measurements on were made on the same day."
• Data Provenance: The specimens were collected from "geographically diverse populations." The document does not specify particular countries but implies a broad collection. The study appears to be prospective in nature, as specimens were "collected" and then "processed as lysed preparations and assayed in parallel" for the purpose of this product testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (monoclonal antibody reagent for flow cytometry) relies on established cellular markers and flow cytometry principles rather than subjective expert interpretation for ground truth. Therefore, there's no mention of "experts" in the traditional sense of adjudicating images or clinical cases. The "ground truth" is inherently tied to the established scientific understanding of CD antigens and their detection via flow cytometry. The reference device, CYTO-STAT® CD3/CD56, serves as the comparison for establishing equivalence, implying its performance is considered the de facto "truth" against which the new device is measured.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. The "ground truth" is determined by the measurements obtained from the predicate device and the consistent application of flow cytometry principles. The performance of the new device is directly compared to these measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers interpreting results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a reagent for flow cytometry, not an algorithm. The "performance" is the ability of the reagent to accurately label cells for subsequent analysis by a flow cytometer, which produces quantitative data. Human operators are involved in specimen preparation, running the flow cytometer, and interpreting the raw flow cytometry data (e.g., gating lymphocytes), but the reagent itself is not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used is comparison to a legally marketed predicate device (CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MsIgG1-RD1/MsIgG1-FITC Isotypic Control). The performance of the new device (CD45/CD56/CD3) was compared to this predicate device (CD3/CD56) using flow cytometry measurements, which are considered quantitative and objective measures for cell populations.

8. The Sample Size for the Training Set

Not applicable. This is a reagent, not an AI model that requires a training set. The development of the reagent involves chemical and biological formulation, not data training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a reagent product.

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