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IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.

IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.

IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.

IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.

IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.

IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.

IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.

IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.

I am unable to find the information about the acceptance criteria or results of a study that proves the device meets the acceptance criteria within the provided text. The document is primarily a 510(k) premarket notification letter from the FDA to IO Corporation, confirming that their IQ Products Triple-Color Flow Cytometry Reagents are substantially equivalent to legally marketed predicate devices.

The document describes the indications for use for several IQ Prep Reagents (CD45 FITC/CD4 R-PE/CD3 CyQ, CD45 FITC/CD8 R-PE/CD3 CyQ, CD45 FITC/CD19 R-PE/CD3 CyQ, and the isotypic control CD45 FITC/IgG1 R-PE/IgG1 CyQ). These reagents are intended to identify and enumerate specific lymphocyte populations in whole blood by flow cytometry.

However, the letter does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Details about any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the training set for any AI/algorithm (as this is a reagent, not an AI device).

This document is an FDA clearance letter, not a detailed study report. Such reports would typically be submitted to the FDA as part of the 510(k) application, but are not usually part of the publicly available clearance letter itself.

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