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The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 mm) laser, two light scatter detection volume (EV). It is used in conjunction with the following reagents and software package.

AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;

• AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent

· Total CD3+, CD3+CD4+,CD3+CD3+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.

• CD45+ absolute count

• · CD45+ Low SS (lymphocytes) percentage and absolute count
  AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent

• · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.

• CD45+ absolute count

• · CD45+ Low SS (lymphocytes) percentage and absolute count

AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.

AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;

• AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent

· Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+(ratio only) lymphocyte percentages and absolute

counts.

• CD45+ absolute count
• · CD45+ Low SS (lymphocytes) percentage and absolute count
• AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent
• · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
• CD45+ absolute count
• · CD45+ Low SS (lymphocytes) percentage and absolute count

AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.

The AQUIOS CL Flow Cytometry System is composed of the following components:

• . AQUIOS CL Flow Cytometer
• AQUIOS System Software ●
• AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 ●
• AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 ●
• AQUIOS Immuno-Trol Cells ●
• AQUIOS Immuno-Trol Low Cells ●
• . AQUIOS Lysing Reagent Kit

The AQUIOS CL Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.

The AQUIOS System Software is designed for the AQUIOS CL flow cytometer. It includes the algorithms and test definitions that provide automated analysis and results for AQUIOS Tetra-1 and 2+ reagents; this application cannot be modified by the user.

The AQUIOS Flow Cytometry System also offers an optional standalone offline workstation. This workstation is identical to the workstation that is physically connected to the instrument and can be used for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with AQUIOS Tetra-1 and Tetra-2+ reagents and AQUIOS System software according to the product labeling.

AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 reagent provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+/CD4+, CD3+/CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+, CD3-/CD19+ and CD3-/CD56+CD16+ lymphocyte percentages and absolute counts in peripheral whole blood. Additionally, both panels provide for CD45+ absolute count and CD45+ Low SS absolute count and percentage.

AQUIOS Immuno-Trol and Immuno-Trol Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

The AQUIOS CL Flow Cytometer uses on-board sample preparation as part of the overall system workflow. The AQUIOS Lysing Reagent Kit is comprised of two readyto-use reagents: Reagent A lyses the red blood cells, Reagent B quenches the solution, slowing the lyse reaction down in preparation for analysis. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.

Here's an analysis of the acceptance criteria and study findings for the AQUIOS CL Flow Cytometry System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides summary results rather than explicit, quantified acceptance criteria for many tests. However, it consistently states that the device "meets performance requirements" or "was demonstrated." Where specific performance measures or outcomes are mentioned, they are included below.

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

The document does not explicitly state the sample sizes used for the test set portion of the studies (which would typically involve independent validation after development). Instead, it describes general testing approaches. It also does not specify the country of origin for the data or whether it was retrospective or prospective.

For example, for "Method Comparison," it merely states "To evaluate bias between the subject device versus the predicate" and uses CLSI EP09-A3 (Method Comparison and Bias Estimation Using Patient Samples), which implies patient samples were used, but no quantity or demographics are given. Similarly, "Adult Reference Intervals" implies a study on adults, but sample size and demographics are not specified.

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

The document does not mention the use of experts to establish a "ground truth" for a test set in the traditional sense of image interpretation or complex diagnostic decision-making. The AQUIOS CL Flow Cytometry System is an automated cell counter. Its "ground truth" for the test set would typically be established by established reference methods, predicate devices, or validated laboratory assays (e.g., manual differential counts, confirmed cell populations by expert flow cytometrists, or validated internal methods). The document refers to "predicate devices" for comparison, which themselves are legally marketed and validated, serving as a de facto "ground truth" in terms of established performance.

4. Adjudication Method for the Test Set

Not applicable. As "ground truth" is not explicitly established by human experts in a subjective interpretation process (like in radiology), an adjudication method in the sense of resolving inter-reader disagreements is not described or implied. The system relies on comparisons to predicate devices and validated methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study, which typically compares human reader performance with and without AI assistance, was not conducted. This device is an automated in vitro diagnostic system for cell counting and immunophenotyping, not a system that assists human readers in interpreting complex cases. Its "effectiveness" is measured by its analytical performance (accuracy, precision, linearity, etc.) against established laboratory methods and predicate devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

Yes, implicitly. The entire set of performance studies described (Fluorescence Linearity, Electronic Volume Linearity, Laser Performance, Analyzer Carryover, Instrument Settings Stability, Gravimetrics, Comparability, Assay Linearity, Assay Carryover, Detection Capability, Specimen and Prepared Sample Stability, Method Comparison, Precision, Adult Reference Intervals, Reagent Stability, Lot Variability) evaluates the device's autonomous performance. The AQUIOS CL Flow Cytometer, along with its reagents and software, is designed to perform these tasks automatically. While human operators are involved in sample preparation and loading, the core measurements and classifications are driven by the instrument's algorithms and hardware, making these standalone performance assessments. The "AQUIOS System Software" also includes algorithms for automated analysis.

7. The Type of Ground Truth Used

The ground truth for the performance studies appears to be based on:

• Comparison to predicate devices: For analytical accuracy (e.g., "Method Comparison" against FACSCalibur or UniCel DxH 800). This means the established, cleared performance of the predicate serves as the standard.
• Validated internal methods/specifications: For various instrument and assay characteristics like linearity, precision, detection limits, and stability.
• Published values: For establishing "Adult Reference Intervals," which were confirmed to be "consistent with published values for T, B, and NK lymphocyte subsets."
• CLSI (Clinical and Laboratory Standards Institute) guidelines and standards: These provide the methodological framework and often implicit performance thresholds for many tests (e.g., CLSI EP06-A for linearity, CLSI EP5-A2 for precision, CLSI H26-A2 for hematology analyzers).

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its size. For an IVD device like this, which performs quantitative measurements based on biophysical properties, the development process generally involves extensive internal testing and refinement (calibration, optimization, verification) using a wide range of samples, rather than a distinct "training set" in the machine learning sense. The performance studies described in the document are primarily for validation and verification.

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

Since a "training set" in the AI/ML context is not explicitly mentioned, the concept of establishing ground truth for it is not directly addressed. Instead, the analytical methods (flow cytometry principles, reagent chemistries, software algorithms) are based on well-established scientific principles and calibrated against reference materials and methods during the device's development and manufacturing.

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