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The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems:

• BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
• BD Multitest IMK Kit with or without BD Trucount Tubes .
• BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
• BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:

• BD Multitest IMK Kit with or without BD Trucount Tubes .
• BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
• BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
• BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
• BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
• BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
• BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
• BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.

The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

Here's a breakdown of the acceptance criteria and study information for the BD FACS™ Sample Prep Assistant III, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document does not explicitly state numerical acceptance criteria for accuracy, precision, or carryover. It refers to established guidelines (CLSI document EP9-A2 for Accuracy, CLSI document EP5-A2 for Precision, and Class II Special Controls Guidance Document for Carryover) which likely define these specifications. The reported performance is qualitative, stating that the device "demonstrated equivalent performance" or was "within specification."

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

• Test Set Sample Size: Not explicitly stated. The "Accuracy" study mentions "Patient Samples," but the number of samples used is not provided.
• Data Provenance: Not explicitly stated. The document describes the device preparing "human whole blood," implying human samples were used, but the country of origin is not mentioned. The studies appear to be prospective, laboratory-based evaluations.

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

This information is not provided in the document. The studies listed (Accuracy, Precision, Carryover) are performance assessments of the automated system itself, not studies relying on interpretation by experts to establish a "ground truth" for diagnostic purposes. The ground truth for these types of studies would likely be objective measurements or comparisons against established manual methods or reference instruments.

4. Adjudication Method for the Test Set:

This information is not provided. As noted above, the studies are performance assessments, not expert-opinion-based diagnostic studies.

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

An MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers interpreting diagnostic images or data, and the BD FACS™ Sample Prep Assistant III is an automated sample preparation device, not an interpretive diagnostic tool.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance assessment was done. The studies listed (Accuracy, Precision, Carryover) are evaluations of the device's performance in preparing samples. The "results" section directly refers to the "SPA III" or "SPA III with the BD FACSCalibur system" demonstrating equivalent performance or being within specification, indicating that the device's automated functions were assessed directly.

7. Type of Ground Truth Used:

The type of ground truth used would be based on objective measurements and comparisons against established reference methods.

• For Accuracy, the "Method Comparison and Bias Estimation" likely compared results from samples prepared by the SPA III to results from samples prepared by a predicate device or a manual, gold-standard method.
• For Precision, the ground truth would be statistical measures of reproducibility and repeatability based on replicate measurements.
• For Carryover, the ground truth would be the absence or minimal presence of analytes from a high-concentration sample in a subsequent low-concentration sample, measured objectively.

8. Sample Size for the Training Set:

This information is not applicable or not provided. The BD FACS™ Sample Prep Assistant III is an automated pipetting and diluting system. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on pre-programmed protocols and mechanical precision, not learned patterns from data.

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

This question is not applicable as the device does not utilize a training set in the context of AI/machine learning. Its "ground truth" for operational accuracy and precision would be established through engineering specifications, calibration, and validation against known standards during its development and manufacturing.

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COULTER TQ-Prep Workstation: Intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indication for Use: Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described in each application's Instructions for Use. For In Vitro Diagnostic Use Only.

COULTER PrepPlus 2: Intended Use: The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indications for Use: Pipetting blood, cleared Beckman Coulter IVD reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For In Vitro Diagnostic Use Only.

The COULTER TO-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for measurement on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

The provided document describes the K130253 510(k) submission for the COULTER TQ-Prep Sample Preparation Workstation and COULTER PrepPlus 2 Workstations. These devices are intended for preparing human whole blood for in vitro diagnostic use with specific Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. The submission focuses on demonstrating substantial equivalence to predicate devices through performance studies.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the test sets in the accuracy, precision, gravimetrics, or carryover studies.

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the studies were conducted to support the 510(k) submission.

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

This information is not provided in the document. The studies described are performance evaluations of an automated pipetting and diluting system, comparing its dispense accuracy, precision, and carryover to predicate devices or established standards. These types of studies typically do not involve "ground truth" established by human experts in the same way, for example, an image analysis study would. The ground truth here would be the actual dispensed volumes or analytical measurements from the flow cytometers.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the nature of a pipetting and diluting system, the "truth" is determined by objective measurements (e.g., gravimetric analysis for dispensed volume, flow cytometer readings for accuracy and precision of sample preparation). Adjudication by human experts is not relevant in this context.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact on diagnostic accuracy. The devices in this submission are automated sample preparation workstations, which do not involve human interpretation of medical images or diagnostic outputs in the manner an MRMC study would evaluate.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies conducted are standalone performance evaluations of the devices (TQ-Prep and PrepPlus 2 workstations). The "performance" being evaluated is the accuracy, precision, and carryover of their automated functions (pipetting, diluting, reagent addition, mixing) as compared to predicate devices or established guidelines (CLSI documents). There is no "human-in-the-loop" aspect to the fundamental performance of these automated systems.

7. The Type of Ground Truth Used

The "ground truth" in these studies refers to:

• For Accuracy and Precision (with reagents): The actual analytical measurements obtained from flow cytometers after sample preparation, which are then compared to results from predicate devices. The assumption is that the predicate devices produce acceptable analytical results.
• For Gravimetrics: The actual weight of dispensed liquids, which directly correlates to the volume dispensed. This is an objective, measurable truth.
• For Carryover: Analytical measurements demonstrating the absence or presence of unwanted sample transfer, using established methods to quantify carryover.

It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective technical and analytical measurements.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. These devices are automated workstations, not AI/ML algorithms that typically require a distinct training set for model development. The reported studies are performance validation studies.

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

As these are automated workstations and not AI/ML models in the typical sense, there is no "training set" or "ground truth for the training set" established in the conventional AI/ML context. The devices are programmed with specific operational parameters, and their performance is then validated through the studies described.

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The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry. This is the same intended use as previously cleared for the BD FACSCanto system with BD FACSCanto clinical software.

Indications for Use:

• Immunophenotyping in clinical laboratories, using previously cleared IVD I assays for flow cytometry that utilize the lyse no-wash sample preparation method.
• Immunophenotyping of lymphocyte subsets including CD3CD8, CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*.
• For in vitro diagnostic use.
• For use with or without the BD FACS Sample Prep Assistant II.

The BD FACSCanto system with BD FACSCanto clinical software is a flow cytometry system designed for analyzing samples prepared with the lyse / no-wash method. The BD FACS Sample Prep Assistant II is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA II combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer.

The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

Device Acceptance Criteria and Study Details:

This document describes the acceptance criteria and study findings for the BD FACSCanto system with BD FACSCanto clinical software, specifically when used with the BD FACS Sample Prep Assistant II (SPA II). The device is intended for the identification and enumeration of lymphocyte subsets in human cells.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided document does not explicitly state numerical acceptance criteria or specific thresholds for "comparable accuracy," "acceptable system precision," or "acceptable system carryover." These are derived from the interpretation of the study design and the reported conclusions. The predicate device (BD FACSCanto system with manual pipetting) serves as the benchmark for comparison.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified in the provided document. The "Accuracy" study mentions "Patient Samples" but does not provide a number.
• Data Provenance: Not specified. It can be inferred that the studies were conducted by the manufacturer, BD Biosciences, but the country of origin of the data (e.g., patient samples) and whether it was retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Not applicable. The document describes studies for accuracy, precision, and carryover of a sample preparation system, not for diagnostic interpretation by human experts. Therefore, no experts were used to establish ground truth in the context of diagnostic assessment. The "ground truth" for these studies would be derived from the reference methods outlined in the NCCLS guidelines for accuracy and precision, and specific carryover protocols.

4. Adjudication Method (Test Set):

• Not applicable, as no expert adjudication was involved in these performance studies.

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

• No, a MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices where human interpretation is a primary component. The BD FACSCanto system is an automated cell counter, and the studies focus on its analytical performance (accuracy, precision, carryover) relative to a manually operated predicate device, not on improving human reader performance.

6. Standalone (Algorithm Only) Performance:

• Yes, a form of standalone performance was assessed. The studies evaluate the performance of the BD FACSCanto system with the automated BD FACS Sample Prep Assistant II (SPA II) as a complete, integrated system. The SPA II itself is an automation component that replaces manual pipetting. The evaluation implicitly defines its "standalone" performance within the context of the overall system's ability to prepare and analyze samples. The comparison is between the automated preparation method and the manual preparation method using the same core BD FACSCanto system.

7. Type of Ground Truth Used:

• The ground truth for the performance studies would be established using reference methods and guidelines defined by NCCLS (National Committee for Clinical Laboratory Standards) documents EP9-A (Accuracy) and EP5-A (Precision). For carryover, it would be based on Class II Special Controls Guidance Document for Automated Differential Cell Counters. These guidelines provide standardized methods for assessing the analytical performance characteristics of laboratory devices, where "ground truth" is determined by well-controlled experiments and established reference measurements (e.g., highly accurate standard solutions or a gold-standard manual method if applicable, for accuracy studies).

8. Sample Size for the Training Set:

• Not applicable. The provided document concerns the performance evaluation of a device, not the development or training of an AI algorithm on a dataset. Therefore, there is no mention of a "training set" in the context of machine learning.

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

• Not applicable, as no training set for an AI algorithm is mentioned or relevant to the described device and studies.

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