Search Results

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

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not explicitly state the numerical sample size for any of the performance studies. It mentions "blood samples from three normal donors" for linearity.
• Data Provenance: The studies were conducted at:
  • Cleveland Clinic (USA)
  • Johns Hopkins Hospital (USA)
  • Institute of Tropical Medicine (unspecified country, but often refers to institutions focused on tropical infectious diseases, frequently in developing countries or with international collaborations)
  • University of North Carolina (USA)
  • Becton Dickinson Immunocytometry Systems laboratories in San Jose, California (USA)
• Retrospective/Prospective: The document does not specify whether the data was retrospective or prospective. Given the nature of a 510(k) submission and performance studies, it's highly likely to be prospective data collection for the purpose of demonstrating device performance, but this is not explicitly stated.

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

The document does not mention the use of experts to establish ground truth or their qualifications. The "ground truth" for this device appears to be comparison against established predicate devices and standard laboratory methodologies rather than expert consensus on individual cases.

4. Adjudication method for the test set

The document does not mention any adjudication method. This type of device (flow cytometry reagent for enumerating cell populations) typically relies on quantitative measurements from instruments calibrated against established standards, rather than subjective interpretation requiring adjudication among experts.

5. 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, an MRMC comparative effectiveness study was NOT done. This device is a diagnostic reagent and tube system for flow cytometry, which is an automated or semi-automated process for cell enumeration. It does not involve human "readers" in the way an imaging AI algorithm would.
• Not applicable for AI assistance. The document predates the widespread regulatory consideration of AI-driven medical devices and does not mention any AI components. The "assistance" for human operators comes from the flow cytometer and associated software, which are standard tools.

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

• Standalone performance was done. The performance studies described (accuracy, reproducibility, linearity, stability) assess the performance of the reagent and tube system in conjunction with a flow cytometer. While a human operates the flow cytometer and analyzes the data, the core "algorithm" and chemical reaction of the device itself are being evaluated. This is effectively a "standalone" evaluation of the device's technical specifications.

7. The type of ground truth used

The ground truth was established by comparison to predicate devices (IMK-Lymphocyte Tube E and the FACSCount System) and standard laboratory methodologies for cell enumeration and characterization. This implies that the predicate devices are considered the "gold standard" or accepted reference for the measurements, and their results serve as the ground truth against which the new device's performance is measured. Linearity and stability studies likely used controlled samples with known or precisely determined values.

8. The sample size for the training set

The document does not mention a "training set" or "training data." This is because the device is a chemical reagent and consumable, not a machine learning algorithm that requires training.

9. How the ground truth for the training set was established

• Not applicable. As stated above, there is no mention of a training set as this is not an AI/ML device.

Ask a specific question about this device