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Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 Monocrollar Wouse First House Anti-Human Mouse Anti-Human Monocyte. CD14, RPE-Conjugated, Clone TUK4 (Anti-CD) 1/RPE, TÜK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenoryping of lymphocytes in peripheral blood.

Purified mouse anti-human CD45, Clone T29/33, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD14, Clone TUK4, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein

Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.

Here's an analysis of the provided text, outlining the acceptance criteria and study details as requested:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Linearity (Anti-CD45/FITC): Not explicitly stated how many individual cells/samples were used, but it involved serial dilutions of Raji (antigenic) and U937 (non-antigenic) cell lines.
   • Reproducibility: 10 replicates from peripheral blood of one donor per test (for each of two flow cytometers and each antibody). Data provenance is DAKO Corporation internal testing.
   • Specificity: 5 apparently healthy adult donors (3 Caucasians, 1 Asian, 1 Hispanic) for basic specificity. Data provenance is DAKO Corporation internal testing.
   • Correlation to Predicate Device: 150 normal, apparently healthy individuals and 27 samples from ill patients. These were tested at three geographically separate laboratories. Data provenance is multi-site, multi-ethnic (implied by "normal, apparently healthy individuals"), and appears to be prospective for the purpose of this comparison.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention experts being used to establish ground truth for the specific performance evaluation (reproducibility, specificity, linearity). These appear to be laboratory measurements against known cell lines or direct observation of antibody binding.
   • For the correlation study against the predicate device, the "ground truth" is essentially the results obtained from the predicate device itself. The document does not specify if experts verified these predicate results.
   • The "Leukocyte Typing Workshops" (Third, Fourth, Fifth) are cited as providing information that contributes to the conclusions, implying a broader expert consensus within the scientific community for the validity of the clones used (T29/33 and TUK4). However, these workshops did not establish the ground truth for this specific device's test set.

3. Adjudication method for the test set:

   • No adjudication method is described for the direct performance studies (linearity, reproducibility, specificity).
   • For the correlation study, duplicate samples were tested with each reagent, suggesting comparative measurement rather than adjudication by experts.

4. 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:

   • No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic reagent and accessory for flow cytometry, not an AI or imaging device where "human readers" typically interpret results with or without assistance in the conventional sense. The "reading" is done by the flow cytometer, and the results are numerical.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not applicable as the device is a reagent for flow cytometry, not an algorithm. The flow cytometer itself performs the "standalone" measurement, and human operators perform sample preparation, instrument setup, and interpretation of the numerical results produced by the instrument. The "algorithm" here would be the flow cytometer's software, which is part of the system the reagent is designed to be used with.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Linearity: Based on known antigenic expression of established cell lines (Raji and U937).
   • Reproducibility: Based on direct measurements from a single donor's peripheral blood run multiple times.
   • Specificity: Based on observed antibody binding to different cell populations (RBCs, granulocytes, monocytes, lymphocytes, platelets) in apparently healthy donors, with cell identification likely based on morphology and characteristic light scatter patterns in flow cytometry, consistent with cellular biology.
   • Correlation to Predicate Device: The "ground truth" for the comparative study was the results obtained from the predicate device (Becton Dickinson Simultest LeucoGATE) on the same samples. These predicate results are assumed to be a valid measurement.

7. The sample size for the training set:

   • This is not applicable. The device is a diagnostic reagent, not a machine learning algorithm that requires a "training set." The development of the monoclonal antibodies (clones T29/33 and TUK4) themselves would have involved extensive R&D, but that is not an "algorithm training set" in the modern sense.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of device.

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