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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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