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For in vitro diagnostic use to identify and enumerate percentages and absolute counts of T and NK lymphocytes in blood.

For use with any flow cytometer with specified detection ranges.
For use with erythrocyte lysed whole blood.
For use with or without an isotype control.
For in vitro diagnostic use.
To identify and enumerate percentages and absolute counts of CD3+ and CD16+CD56+ lymphocytes in normal individuals and patients with certain tumors and viral infections

The BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD16+CD56 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Natural Killer lymphocytes (CD3- and CD16+ and/or CD56+) in erythrocytelysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/uL. The Becton Dickinson TriTEST/TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (TriTEST CD3 FITC/CD16+CD56 PE/CD45 PerCP) and TRUCOUNT Absolute Count Tubes.

The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage.

To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is P x (beads/pellet)/(volume of blood sample).

When monoclonal antibody reagents are added to human whole blood, the fluorochromelabeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam.

The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.

This document describes the Becton Dickinson TriTEST™ reagent CD3 FITC/CD16+CD56 PE/CD45 PaCP; TRUCOUNTTM Absolute Count Tubes.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes performance characteristics and concludes that the device is "as safe and effective as the predicate device" based on these studies. The equivalence to predicate devices (Simultest IMK-Lymphocyte Tube F for percentages, and Simultest IMK-Lymphocyte Tube F plus ADCC for absolute counts) is the primary "acceptance criterion" indirectly.

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

The document provides some information about sample sizes but is not comprehensive for all studies.

• Accuracy Studies: Not explicitly stated. The studies were performed at "Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina, and at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California." This implies a prospective design across multiple geographical locations (USA and potentially international due to "Institute of Tropical Medicine").
• Within-specimen Reproducibility:
  • BDIS: 10 replicates from 3 specimens.
  • 3 Clinical Sites: 3 aliquots from each donor (number of donors not specified).
• Linearity: Blood samples from 3 normal donors.

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

The document does not specify the number of experts or their qualifications used to establish ground truth. It mentions "testing at Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina, and at Becton Dickinson Immunocytometry Systems laboratories." This implies clinical laboratory professionals were involved, but their specific roles, number, and qualifications (e.g., medical technologists, pathologists, immunologists, experience levels) are not detailed.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or resolving discrepancies in the test results. The studies focused on demonstrating equivalence to predicate methods, implying direct comparison rather than a separate expert-driven ground truth adjudication process.

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:

This device is not an AI-assisted diagnostic tool. It is a reagent and system for flow cytometry. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The device is a system comprising reagents, tubes, and analysis performed on a flow cytometer. While the analysis part involves computing ratios and identifying regions, it's not described as a standalone "algorithm" in the modern AI sense. The performance assessment implicitly covers the entire system's ability to enumerate cell populations, which is an automated process once the sample is prepared and run on the flow cytometer.

7. The Type of Ground Truth Used:

The ground truth for establishing performance (particularly accuracy) was based on comparison to predicate devices/methods:

• For percentages: Simultest IMK-Lymphocyte Tube F.
• For absolute counts: Simultest IMK-Lymphocyte Tube F plus automated differential cell counter (ADCC).

This is a clinical comparison against established and predicate laboratory methods, rather than pathology, expert consensus (in the sense of independent review of an image), or outcomes data.

8. The Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning or AI algorithms is not applicable here. This device is a biochemical reagent and flow cytometry system, not a learning algorithm. The studies described are performance validation studies, not training.

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

As mentioned above, there is no "training set" in the AI sense for this device. The performance was validated against established predicate methods.

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