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The CELL-DYN® 3000 Series are automated, multi-parameter hematology analyzers intended for in-vitro diagnostic use in the Clinical Laboratory and the Physician's Office Laboratory (POL).
The Cell-Dyn® 3000 Series instruments process human whole blood specimens to provide a hemogram with automated differential.

The CELL-DYN® 3000 Series instruments each consist of three major modules: the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; the Data Station/Module, which controls all system processing and provides the primary operator interface with the system; and the Printer, which generates reports automatically or on demand.
The CELL-DYN® 3000 Series instruments are designed to analyze K3EDTA anticoagulated human whole blood specimens and report the hematological parameters shown in the table on the following page:
Reported Parameters: White Blood Cell Parameters (WBC, NEU, %N, LYM, %L, MONO, %M, EOS, %E, BASO, %B), Red Blood Cell Parameters (RBC, HCT, MCV, RDW, RETC (CELL-DYN 3500R only), MCH, MCHC), Platelet Parameters (PLT, MPV, *PDW, *PCT), Hemoglobin Parameters (HGB). * These parameters are provided for laboratory use only and are not reportable in the US.

This document describes a 510(k) submission to expand the intended use of the Abbott CELL-DYN® 3000 Series Hematology Systems to include Physician's Office Laboratories (POLs). The submission focuses on demonstrating the substantial equivalence of these devices for use in POLs.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define numerical acceptance criteria in a table format. Instead, it states that "Accuracy, precision, and linearity data show performance to manufacturer's specifications." The study aims to demonstrate equivalence, implying that the performance of the CELL-DYN® 3200 in a POL setting meets the established performance of the CELL-DYN® 3500R and CELL-DYN® 3000, which are already cleared for clinical laboratory use.

The reported device performance is described as demonstrating "equivalence" between the CELL-DYN® 3200 System and the CELL-DYN® 3500R System for the following measured parameters:

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "the data compiled to support the claim" and "accuracy, precision, and linearity data."

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

This information is not provided in the document. The study focuses on demonstrating analytical performance equivalence between automated hematology analyzers, not on expert interpretation of results.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the device (automated hematology analyzer), human adjudication of ground truth in the traditional sense is unlikely to be a primary method for establishing analytical performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation of images or other subjective data. This submission is for an automated hematology analyzer assessing analytical performance.

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

Yes, the studies described are inherently standalone performance evaluations. The CELL-DYN® 3000 Series are automated instruments. The equivalency data for background, accuracy, precision, linearity, and carryover are all measures of the algorithm's (device's) analytical performance independent of human intervention in the result generation.

7. The Type of Ground Truth Used:

The ground truth for this type of analytical device would typically be established through:

• Reference Methods: Using established, highly accurate reference methods for each hematological parameter.
• Calibrators and Controls: Utilizing commercially available or in-house manufactured calibrators and controls with known values.
• Inter-instrument Comparison: Comparing results to a legally marketed predicate device (in this case, the CELL-DYN® 3500R) that has already proven accurate performance.

The document states that "Equivalence is demonstrated between the CELL-DYN® 3200 System and the CELL-DYN® 3500R System," suggesting the latter served as a reference or "ground truth" for the comparison of analytical performance.

8. The Sample Size for the Training Set:

This information is not provided. The document describes a 510(k) submission for expanding the intended use of existing devices, not the development or training of a new algorithm. Therefore, "training set" in the context of machine learning is not directly applicable here. The devices are based on established principles of operation (flow cytometry, laser optical scatter, impedance, optical absorbance) rather than machine learning models that require explicit training sets.

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

As mentioned above, the concept of a "training set" in the machine learning sense is not applicable to this submission. The devices operate based on physical principles of cell analysis. The "ground truth" for the initial development and calibration of these instruments would have been established through rigorous analytical validation using reference methods, calibrators, and known clinical samples.

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