(68 days)
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.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”