Search Results

The FlowCARE PLG CD4 Reagent is for use on the Coulter® EPICS® XL ™/XL-MCL™ or equivalent flow cytometer. The reagent kit combines two fluorescent-labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage in combination with a White Blood Cell (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count ™ Fluorospheres as a single platform measurement.

The FlowCARE PLG CD4 Reagent consists of a two-color antibody reagent composed of CD45-FITC and CD4-PE. The assay is performed on the EPICS XL, Cytomics FC 500, or equivalent Flow Cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres for determination CD4 absolute counts as a single platform measurement, or in combination with a White Blood Cell Count from a hematology analyzer as a dual platform measurement.

The provided document, K043215, "FlowCARE PLG CD4 Reagent," is a 510(k) summary for a medical device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the typical format of a clinical trial or performance study report.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This is a common regulatory pathway for medical devices where the manufacturer shows that their new device is as safe and effective as a legally marketed device (the predicate device) that is already cleared by the FDA.

Therefore, the specific questions outlined in your request related to acceptance criteria, sample size, ground truth, experts, adjudication, MRMC studies, and standalone performance for proving device acceptance are not explicitly addressed or applicable in this type of regulatory submission. The document emphasizes comparison and similarities to an existing cleared device rather than presenting novel performance data against pre-defined acceptance criteria.

Here's why and what information can be extracted or inferred:

• Acceptance Criteria and Reported Device Performance: This document does not present a table of acceptance criteria for the FlowCARE PLG CD4 Reagent's performance. Instead, it highlights that the device "claims substantial equivalence" to the predicate device (tetraONE SYSTEM) for the enumeration of CD4 T-Lymphocytes. The "performance" is implicitly deemed acceptable because it is considered equivalent to a device already on the market.
• Study Data (Sample Size, Provenance): There is no mention of a specific "test set" sample size or data provenance (country, retrospective/prospective). The document discusses the device's components and intended use, comparing them to the predicate. Any underlying data supporting the "equivalence" would have been part of the manufacturer's internal validation, but it's not detailed in this public summary.
• Number of Experts, Qualifications, Adjudication: These details are not relevant for a 510(k) summary of substantial equivalence. No expert review of specific cases or adjudication process is described as the primary mechanism for demonstrating device performance.
• MRMC Comparative Effectiveness Study: No MRMC study is mentioned. The focus is on the device's characteristics and its equivalence to a predicate, not on how human readers' performance might improve with or without AI assistance (which is not applicable here as it's a reagent, not an AI system for interpretation).
• Standalone Performance: The document describes the reagent's function as an "algorithm only (without human-in-the-loop performance)" is not applicable. The FlowCARE PLG CD4 Reagent is a biological reagent kit used in conjunction with flow cytometers and other laboratory equipment for in vitro diagnostic testing. The performance is the output of the instrument-reagent system.
• Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is not discussed in the context of validating this device's performance against a standard. The performance is compared to that obtained using a predicate device.
• Training Set Sample Size and Ground Truth Establishment: This information is also not included. The device is a diagnostic reagent, not a machine learning algorithm that requires a "training set" in the conventional sense.

In summary, while the request asks for specific details about acceptance criteria and performance studies, the provided document (a 510(k) summary for substantial equivalence) does not contain this information because its purpose is to demonstrate equivalence to an already cleared device, not to present new performance data against pre-defined acceptance criteria in a detailed study report.

Ask a specific question about this device

The tetraCXP SYSTEM for the Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and CXP software. The system with CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. The system with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.

tetraCXP SYSTEM for the Cytomics FC 500 with CXP Software consists of CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD-45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and automated application and operating software on the Cytomics FC 500 Flow Cytometer.

This document is a 510(k) Summary for the tetraCXP SYSTEM for the Cytomics FC 500 with CXP Software. It describes a device intended for "in vitro diagnostic use" for the simultaneous identification and enumeration of lymphocyte subpopulations in whole blood.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide detailed performance data for the tetraCXP system. Instead, it relies on demonstrating substantial equivalence to a predicate device. This is a common approach in 510(k) submissions, where a new device's safety and effectiveness are established by showing it is at least as safe and effective as a legally marketed predicate device.

The "Comparison to Predicate" table highlights similarities and differences between the new tetraCXP System and the predicate tetraONE System. The key similarity underpinning the substantial equivalence claim is the "Automated Analysis Algorithm": the tetraCXP System uses an algorithm described as "Based on cellSTAT 3D™ algorithm," which is the same as the predicate's "cellSTAT 3D™ algorithm." This implies that the core analytical performance is expected to be similar.

Missing Information:

Crucially, the provided text does not contain the detailed study data, acceptance criteria, or performance metrics that would typically be found in a comprehensive study report proving the device meets specific performance targets. The 510(k) summary is a high-level overview.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative targets in the provided document. The acceptance criterion is implied to be "substantially equivalent" to the predicate device's performance.
• Reported Device Performance: No specific quantitative performance data (e.g., accuracy, precision, sensitivity, specificity, correlation coefficients) are reported in this summary. The device's performance is implicitly judged to be equivalent to the predicate due to the use of similar technology and algorithms.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

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

• MRMC Study Done?: No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for imaging devices where human interpretation is a critical component, rather than for automated cell counters.
• Effect Size of Human Reader Improvement with AI vs. Without AI: Not applicable, as this is an automated device and an MRMC study is not indicated.

6. Standalone (Algorithm Only) Performance:

• Standalone Performance Done?: Yes, the entire device functions as a "standalone" automated analysis system. The text indicates "automated analysis of lymphocyte subpopulations" and "automated analysis algorithm," suggesting the algorithm operates without direct human intervention in the analysis process once the sample is loaded. However, no specific performance metrics for this standalone operation are provided in the summary.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated. For automated cell counters, the ground truth is typically established by manual differential counts performed by trained laboratory technologists (often on stained smears), or by comparison to a reference method (e.g., another established flow cytometry method). The document's claims of substantial equivalence to a predicate device imply that the predicate's established performance serves as a de-facto reference for expected accuracy, but the specifics of how the ground truth was established for this specific device's validation are not detailed.

8. Sample Size for the Training Set:

• Sample Size: Not specified in the provided text.

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

• How Ground Truth Established: Not specified in the provided text.

In summary:

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study methodologies and performance statistics. While it implies that the device meets performance criteria by virtue of its similarity to a legally marketed device, it does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, expert involvement, or concrete performance data. This information would typically be found in the full 510(k) submission or associated validation reports, which are not included here.

Ask a specific question about this device