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The FlowCare System is an automated immune hematology system intended for in vitro diagnostic use in the direct enumeration of White Blood Cell populations and certain T-lymphocyte subsets from human whole blood.

Whole blood samples can be analyzed with the FlowCare™ System for the following parameters:

White Blood Cell Count .
Lymphocyte Percentage (of White Blood Cells)
. Lymphocyte Number
CD4 T-Lymphocyte Count .
CD4 Percentage (of total Lymphocytes) .

The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Device Description

The FlowCare System is a compact benchtop immune hematology system that reports CD4 T-Lymphocyte count and percentage in conjunction with White Blood Cell (WBC) count, and total Lymphocyte count and percentage from analysis of a whole blood sample. The FlowCare System is comprised of an analysis instrument, a touch screen computer and a standard inkjet printer. The FlowCare CD4 Reagent Kit is used in conjunction with the FlowCare System.

All assay steps are performed on whole blood with capped bar-coded reagent tubes designed for use on the FlowCare System. All assay aspiration, dispensing and mixing steps are automated. The FlowCare System reports parameter results on the basis of software analysis of light scatter measurements with the use of nonfluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FlowCare™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the FlowCare™ System in various studies but does not explicitly state quantitative acceptance criteria or thresholds for metrics like accuracy, sensitivity, or specificity. Instead, it uses qualitative statements about the results. Therefore, the table below reflects the qualitative findings as reported.

Acceptance Criterion (Implicit)	Reported Device Performance
Electrical Safety	Found to be in compliance with applicable requirements of UL 61010A-1, CSA C22.2 1010-1, EN 61326-1, and EN 55011 (CISPR 11).
Precision (Within-run & Total)	Acceptable precision demonstrated by replicate measurements of control materials for three days and within-day precision using whole blood samples.
Linearity	Linearity was demonstrated for all measured parameters (including CD4 count in the low range) over a wide range of cell concentrations.
Carryover	Negligible carryover was observed.
Clinical Performance (Comparison to Reference Methods)	Analyses of pooled data showed comparable means and ranges for the FlowCare™ and reference method parameters. (Specific metrics like correlation coefficients, bias, or agreement rates are not provided in this summary.)
Establishment of Normal Values Reference Range	An expected normal values reference range for the FlowCare™ method was determined.

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: A total of 414 evaluable samples were analyzed in the multi-site prospective clinical study.
Data Provenance: The study was a prospective study conducted at four investigational sites. The country of origin of the data is not explicitly stated, but given the FDA review and the sponsor's location (Ashland, MA), it is highly likely that the data originated from the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It states that "analyses were performed for comparison of the FlowCare method to the reference methods," implying that the reference methods provided the ground truth.

4. Adjudication Method:

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

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The clinical study compares the FlowCare™ System's performance to "other commercially available methods" (reference methods), not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance study was done. The FlowCare™ System is described as an "automated immune hematology system" where "automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." This indicates that the device operates as an algorithm-only (standalone) system without direct human intervention in the interpretation of results for the listed parameters. The clinical testing evaluates this standalone performance against reference methods.

7. Type of Ground Truth Used:

The ground truth used for the clinical study was based on "other commercially available methods" (reference methods). These reference methods would likely be established and validated laboratory tests (e.g., flow cytometry or hematology analyzers) that are considered the standard for measuring White Blood Cell populations and T-lymphocyte subsets.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It only describes the performance and clinical validation studies. As it is a 510(k) summary, specific details about the internal algorithm development and training data are typically not included.

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

The document does not provide information on how the ground truth for the training set was established. This detail would typically be part of the algorithm development process, which is not described in this 510(k) summary.

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