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The OScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDT A whole blood:

• White blood cell count (WBC)
• · Neutrophils (NEUT#)
• · Lymphocytes (LYMPH#)
• · Monocytes (MONO#)
• · Eosinophils (EOS#)
• · Basophils (BASO#)
• · Immature Granulocytes (IG#)
• · Percent Neutrophils (NEUT%)
• Percent Lymphocytes (LYMPH%)
• · Percent Monocytes (MONO%)
• · Percent Eosinophils (EOS%)
• · Percent Basophils (BASO%)
• · Percent Immature Granulocytes (IG%)
• · Neutrophil to Lymphocyte Ratio (NLR)

The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. It includes the QScout Lab analyzer, the QScout RLD (Rapid Leukocyte Differential) test, software, and handheld barcode scanner. The QScout system reports white blood cell count and neutrophil to lymphocyte ratio and enumerates and classifies six white blood cell types including immature granulocytes.
The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the QScout Lab and QScout RLD.

Note: The provided document primarily focuses on demonstrating substantial equivalence to a predicate device through various performance studies (method comparison, repeatability, reproducibility, detection limits, linearity, interference, stability, and flagging studies for clinical sensitivity). It does not explicitly define a single, overarching "acceptance criteria" table with pre-defined thresholds for all parameters, but rather implicitly defines acceptance through CLSI guidelines and successful outcomes of the tests. The "reported device performance" is the results shown in the tables.

1. Table of Acceptance Criteria and the Reported Device Performance

As noted above, a single clear table of acceptance criteria with numerical thresholds is not presented. Instead, acceptance is demonstrated by meeting the "pre-defined acceptance criteria" for various studies, often referencing CLSI standards. The reported device performance is provided in the tables and textual summaries of each study.

Here's a synthesized table based on common analytical performance metrics found in the document:

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The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.

MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.

MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.

MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.

The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.

The Early Sepsis Indicator (ESI) requires the use of the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and its reagents, controls and calibrators last cleared under 510(k) K140911.

The UniCel DxH 800 Coulter Cellular Analysis System contains a quantitative, automated hematology analyzer (DxH 800) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). This submission adds a new parameter, Monocyte Distribution Width (MDW) to those mentioned above. This parameter has been shown to aid in the early detection of Sepsis in emergency room patients.

The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).

Here's the breakdown of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance for UniCel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

The device is intended for the quantitative measurement of Monocyte Distribution Width (MDW) to aid in identifying adult patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission. The key acceptance criterion for clinical accuracy revolves around sensitivity and specificity at a specified MDW cut-off.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the study demonstrated that an MDW cut-off of 20.0 units provided an optimum diagnostic ability by balancing the ability to detect positive patients (sensitivity) and negative patients (specificity), and thus this cut-off was selected. Detailed numerical values for sensitivity and specificity at this cut-off are not explicitly provided in the table, but the text assures they met the acceptance criteria.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for the "test set" in a distinct way, but the "Clinical Accuracy" study states it was a "multi-center prospective cohort study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Primarily prospective. The clinical accuracy study was a "multi-center prospective cohort study."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Note: The document mentions "clinical information and diagnostic testing" and "other laboratory findings" were used in conjunction with MDW values, implying expert judgment in establishing the ground truth for sepsis diagnosis.

4. Adjudication Method

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device measures a quantitative biomarker (MDW) from a blood sample, not something interpreted by human readers from images or complex data.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the fundamental performance assessed is the standalone diagnostic ability of the MDW parameter as an aid in identifying sepsis. The clinical accuracy study directly evaluated the MDW parameter's performance in detecting sepsis.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for sepsis diagnosis was established based on "other laboratory findings and clinical information" and "diagnostic testing." This suggests a comprehensive clinical diagnosis of sepsis, likely involving a combination of clinical assessment, laboratory parameters (beyond MDW), and potentially culture results or other confirmatory tests, as determined by clinicians.

8. Sample Size for Training Set

• Sample Size for Training Set: Not explicitly stated as a separate "training set" in the context of machine learning model development. The document focuses on the validation of the MDW parameter and its cut-off.

Note: The MDW parameter itself is a quantitative measurement derived from hematology analyzer data, not a machine learning model that would typically have a distinct training set in the conventional sense. The "training" or development of the algorithm to calculate MDW would have occurred prior to this validation study, but details are not provided here.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not specified, as a distinct training set for a machine learning model is not explicitly mentioned or implied for the MDW parameter's development in this document. The MDW value is a quantitative measurement from the analyzer, not a diagnosis itself.

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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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