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For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood.
For use with any flow cytometer equipped with a 488 mm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and > 650 nm.
For use with erythrocyte lysed whole blood.
For use with or without an isotype control.
To characterize and monitor forms of autoimmune diseases, such as lupus.
To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or AIDS.

The BDIS Trilles T CD3 flucescein isothiocyanate (FITC)/CD8 phycocrythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunoflucrescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Tsuppressor/cytotoxic (CD3+CD8+) cells in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/JL. The Becon Dickinson Trill BT/TRUCOUNT system for immunophenoryping consists of a flow cycometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD8 PE/CD45 PerCP) and TRICOUNT 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 crometric 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 I x (beads/pellet)/(volume of blood sample).
When monoclonal antibody reagents are added to human whole blood, the flucrochrome-labeled 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 fluctochrome-labeled antibodies and the crythrocytes 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 excired by a laser beam.
The three-color reagent permits identification of lymphocyte subsers using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45positive population using a combination of fluorescence and side scatter parameters. By gaing on the CD45-positive population, a maximum number of lymphocyces may be caprured in the gate and non-lymphocyte contamination may be minimized.

The provided text describes the Becton Dickinson TriTEST™ reagent and TRUCOUNT™ Absolute Count Tubes system. This device is intended for in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood using flow cytometry. The primary claim in the document is about substantial equivalence to predicate devices rather than meeting specific performance criteria against predefined thresholds.

Therefore, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate devices, IMK-Lymphocyte Tube E and the FACSCount System. The "reported device performance" is framed as its equivalence to these predicate devices.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

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