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BD FACSPresto System:
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
· For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
· For use in children, adolescents, and adults.
· For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
· Not for point-of-care use.
· For in vitro diagnostic use.

BD FACSPresto CD4/Hb Cartridge & BD FACSPresto CD4/Hb Cartridge Kit:
The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
· For use in children, adolescents, and adults
· For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
· Not for point-of-care use.
· For in vitro diagnostic use.

BD Multi-Check Control:
The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.

BD Multi-Check CD4 Low Control:
The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and data analysis.
The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.

Eurotrol FACSPresto Hb Control:
Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPrestoTM System.

The BD FACSPresto System is an accurate, robust, and portable CD4, %CD4, and hemoglobin (Hb) System. The BD FACSPresto System has fluorescence microscopy and light absorbance capabilities. In addition, the instrument has integrated BD FACSPresto Software and instrument quality controls.
The BD FACSPresto CD4/Hb Cartridge contains antibody-fluorophore conjugates dried on a reagent disc and is embedded with reagent quality controls. The cartridge is designed with onboard reagents that mix well into the blood sample, and enumerate cells populations using fluorescence only. The cartridge is designed with fluidic properties that distribute a sufficient volume and sample into the imaging field of view for precise cell counting.
The BD FACSPresto CD4 and %CD4 assays are designed to stain cells with antibody-fluorophore conjugates for three color fluorescence reading using the BD FACSPresto System. CD4 PE-Cy5 stains CD4-positive cells; while CD3-APC and CD45RA-APC stains total lymphocytes for use in the %CD4 calculation (CD3 stains T cells, while CD45RA stains B and NK cells in a patented formulation). CD14-PE is used for staining monocytes to exclude CD4 and/or CD45RA expressing monocytes from analysis.
BD Multi-Check Control and BD Multi-Check CD4 Low Control are process controls for the CD4 and %CD4 assay on the BD FACSPresto system. They are composed of human leukocytes and erythrocytes in a stabilizing medium and are intended to be used as a complete process control for antibody staining. instrument performance, and data analysis on the BD FACSPresto system.
The BD FACSPresto Hb assay is performed by a spectrophotometric method. using absorbance at an isobestic point for multiple forms of hemoglobin, with correction for scatter. The cartridge microfluidic channel permits absorbance reading of blood and of a reference area.
Eurotrol FACSPresto Hb Control is used as a process control for the Hb assay on the BD FACSPresto system. It is composed of purified bovine hemolysate and is intended to be used as an assayed hemoglobin process control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto System.

Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BD FACSPresto System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally described as meeting CLSI document standards and "study acceptance criteria" or "acceptable results." Specific quantitative targets are less frequently provided in this summary but are indicated as having been met.

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • Bench Method Comparison: VP, N = 107 (CD4 & %CD4); FS, N = 84 (CD4 & %CD4); VP, N = 84 (Hb); FS, N = 108 (Hb)
  • Bench Precision: Streck CD-Chex Plus (Normal and CD4-Low) N = 168; Eurotrol FACSPresto Hb Controls (Levels 1-3) N = 252.
  • Bench Linearity: N = 33 for each parameter (CD4, Lymphocyte, Hb).
  • Hemoglobin Assay Traceability: N = 4-20 depending on bin.
  • Analytical Sensitivity (CD4): LoD N = 60, LoQ N = 180.
  • Analytical Sensitivity (Hb): LoD N = 300, LoQ N = 60.
  • Clinical Method Comparison: N = 796 venous, N = 692 capillary (normal and HIV infected subjects).
  • Clinical Linearity: Number of prospectively procured specimens not explicitly stated, but "low and high concentration pools were created from a specimen".
  • Clinical Sample Stability: Number of samples not explicitly stated.
  • Reference Intervals: Number of adults in "normal reference cohort" not explicitly stated.
• Data Provenance:
  • The text indicates that clinical studies involved "De-identified and delinked prospectively enrolled normal and HIV infected subjects from 8 clinical sites" for method comparison and prospectively procured specimens for clinical linearity.
  • Bench studies were likely conducted in-house.
  • Country of origin is not explicitly stated, but the submission is to the U.S. FDA by BD Biosciences, a U.S.-based company, suggesting U.S. or international data accepted by U.S. regulatory bodies. The reference to "Clinical Validation data was collected at 3 clinical trial sites" (for controls) also implies clinical settings.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

A MRMC comparative effectiveness study was not conducted as described for AI vs. human readers. This device is an automated diagnostic system for laboratory parameters, not an interpretation aid for human readers.

6. Standalone Performance

Yes, standalone performance was done. The entire summary describes the performance of the BD FACSPresto System (algorithm only without human-in-the-loop for result generation) in directly quantifying CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration. The system is an "automated multicolor fluorescent imaging cytometer and absorbance spectrometer."

7. Type of Ground Truth Used

The ground truth used was based on:

• Comparison to predicate and reference devices:
  • For CD4 and %CD4: BD FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes (flow cytometry, a recognized standard).
  • For Hb: Sysmex Automated Hematology Analyzer KX-21N (automated hematology analyzer using absorbance spectrophotometry, a recognized standard) and the HiCN method for hemoglobin determination (a recognized reference method).
• CLSI (Clinical and Laboratory Standards Institute) guidelines: Many performance characteristics (precision, linearity, analytical sensitivity, interference, specimen stability, reference intervals) were evaluated against CLSI standards, implying that these standards define the acceptable "ground truth" or clinical validity for such measurements.

8. Sample Size for Training Set

The document does not explicitly state the sample size used for a "training set." This device is a diagnostic instrument system, not a machine learning algorithm in the typical sense that would have a distinct training phase with a dedicated dataset described in this way. The development and calibration would typically involve extensive internal data, but the summary focuses on verification and validation studies.

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

As no specific "training set" is described for algorithm training in the context of typical machine learning, no method for establishing ground truth for such a set is provided. The development of the instrument's algorithms and parameters would have relied on established laboratory methods and scientific principles for cell counting and hemoglobin measurement, likely validated against gold standard instruments and methods during product development.

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