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For In Vitro Diagnostic Use Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + - Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow cytometry for the analysis of CD3 and CD4* T-cells. This reagent allows simultaneous detection and quantification of CD3CD4 cells (CD4 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.

Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD4, Clone MT310, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaNo, 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, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the correlation "approached a direct 1:1 comparison," which is a qualitative description supporting the quantitative correlation of >0.96. The document doesn't explicitly list "acceptance criteria" but rather presents "technological performance characteristics" that were evaluated. The table above frames these evaluations as implicit acceptance criteria based on the demonstrated performance.

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

• Sample Size: The document mentions "peripheral blood samples obtained from apparently healthy adults." It does not specify an exact number of samples or subjects.
• Data Provenance: The data appears to be prospective as it describes the completion of "flow cytometric tests of peripheral blood samples." The country of origin is not explicitly stated.

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

• The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here.
• The ground truth in this context is established by the predicate devices (DAKO CD3/FITC and DAKO CD4/RPE), which are previously FDA-cleared monoclconal antibodies for measuring CD3 and CD4+ T-cells using flow cytometry.
• The initial validation of the antibody clones (UCHT1 for CD3 and MT310 for CD4) was done at international workshops: the First Leukocyte Typing Workshop (Paris, 1982) and the Second Leukocyte Typing Workshop (Boston, 1984), respectively. These workshops involved numerous scientific experts in immunology and cell typing, whose collective findings established the specificity and identity of these markers.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1) is mentioned, nor is it typically relevant for this type of in vitro diagnostic device. The comparison is against established predicate devices, which serve as the reference.

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating cases with and without AI assistance to measure improvements in diagnostic performance. The device described is a flow cytometry reagent, not an AI-powered diagnostic imaging tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the study is essentially "standalone" in principle, but the concept of "algorithm" is different. The device itself (the reagent) is evaluated for its direct performance in detecting and enumerating cell populations using flow cytometry. While a human operates the flow cytometer and interprets the data, the performance being tested is that of the reagent itself in yielding accurate counts when compared to a reference standard (predicate devices). There is no "AI algorithm" involved in the sense of a software interpreting images or other complex data autonomously.

7. Type of Ground Truth Used

• The ground truth is established by the performance of predicate devices (DAKO CD3/FITC and DAKO CD4/RPE), which are themselves previously cleared and validated reagents for the accurate measurement of CD3 and CD4+ T-cells.
• Further foundational ground truth for the antibody clones was established through expert consensus (clustering at leukocyte typing workshops) regarding their specificity for the target antigens.

8. Sample Size for the Training Set

• The document does not report a separate "training set" in the context of an algorithm or machine learning model. This is an immunoassay reagent, not an AI device. The development of the reagent involves laboratory work, but not "training data" in the AI sense.

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

• Since there's no "training set" for an algorithm in this context, this question is not applicable. The development of the individual antibody clones (UCHT1 and MT310) involved extensive biological research and validation, including the clustering at leukocyte typing workshops, to establish their specificity and utility.

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For In Vitro Diagnostic Use

Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human T-cell, CD8/RPE, DK25 (DAKO Anti-CD3/FITC and Anti-CD8/RPE) has been developed for use in flow cytometry for the analysis of CD3+ and CD8+ T-cells. This reagent allows simultaneous detection and quantification of CD3+CD8+ cells (CD8 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.

Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD8, Clone DK25, 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 a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a numerical sample size for the test set. It mentions "peripheral blood samples obtained from apparently healthy adults."
• Data Provenance: The data is from "peripheral blood samples obtained from apparently healthy adults." The country of origin is not specified, but the manufacturer is DAKO Corporation, located in Carpinteria, CA, USA, suggesting the study was likely conducted in the USA or a region where their products are distributed. The study appears to be prospective as it involves clinical evaluation comparing the new combined reagent to existing predicate devices.

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

• This information is not provided in the summary. The ground truth appears to be established by the performance of the predicate devices themselves, which are already FDA-cleared. The comparison is against these established methods.

4. Adjudication Method:

• This information is not provided. The study design focuses on direct comparison of the new combined reagent with predicate single reagents.

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

• No, an MRMC comparative effectiveness study was not done. This document describes a comparison between a new combined reagent and existing single reagents for flow cytometry, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a standalone performance assessment was done. The device itself is a reagent (Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human T-cell, CD8/RPE, DK25) used in flow cytometry. The study evaluates the performance of this reagent quantitatively (e.g., correlation coefficients for cell measurement, linearity), independent of human interpretation of the final flow cytometry data. The "performance characteristics have been established by clinical evaluation... compared to the individual single reagent predicate devices."

7. The Type of Ground Truth Used:

• The ground truth is based on the performance of previously FDA-cleared predicate devices. Specifically, DAKO Monoclonal Mouse Anti-Human T-cell, CD3/FITC, UCHT1 (K942797) and DAKO Monoclonal Mouse Anti-Human suppressor/cytotoxic T-cell, CD8/RPE, Clone DK25 (K944253). The implicit assumption is that these predicate devices provide an accurate measure of CD3+ and CD8+ cells.

8. The Sample Size for the Training Set:

• This information is not applicable as the device is a reagent, not a machine learning algorithm that requires a training set. The "training" in this context refers to the development and validation of the reagent itself.

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

• This information is not applicable for the same reason as point 8. If "training" refers to the development of the reagent, the establishment of its characteristics would have involved laboratory methods, chemical analysis, and potentially early comparison tests, but not in the sense of a machine learning algorithm's "training set ground truth." The document does mention "Leukocyte Typing Workshops" where antibody clones were clustered, indicating a consensus-based approach to defining these cell markers.

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