Search Results

tetraCHROME Reagents:
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers. The reagents may also be used with the tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or with tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers.

Used alone or in combination with the automated systems, the reagents are intended "For In Vitro Diagnostic Use" and allow simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5.

tetraCXP SYSTEM:
The tetraCXP Software for Cytomics FC 500 flow cytometry systems, CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and CYTO-STAT tetraCHROME CD45-FITC/CD56-RDI/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents combine four-color fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using Cytomics FC 500 flow cytometry systems with CXP Software.

The system with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ T lymphocyte population percentages and absolute counts. The system also provides the CD4/CD8 ratio.

The system with CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+ (T), CD19+(B), and CD3-/CD56+ (NK) lymphocyte population percentages and absolute counts. This reagent reflects the distribution of the three major subsets comprising the lymphocyte population upon which other lymphocyte enumeration studies are based.

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent: This monoclonal antibody reagent identifies a lymphocyte gate based on CD45 bright positive staining (vs. side scatter) and allows simultaneous identification and enumeration of total CD3+, total CD4+ total CD8+, dual-positive CD3+/CD4+ and dual-positive CD3+/CD8+ lymphocytes in whole blood by flow cytometry. The reagent is comprised of four murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent is for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers with a manual gating procedure provided in the reagent product labeling. The reagent may also be used with the automated algorithm gating provided by tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers.

CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent: This monoclonal antibody reagent identifies a lymphocyte gate based on CD45 bright positive staining (vs. side scatter) and allows simultaneous identification and enumeration of total CD3+, CD19+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. The reagent is comprised of four murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent is for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers with a manual gating procedure provided in the reagent product labeling. The reagent may also be used with the automated algorithm gating provided by tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers.

tetraCXP SYSTEM: tetraCXP SYSTEM for the Cytomics FC 500 with CXP Software consists of tetraCXP SYSTEM application software, tetraCHROME monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and automated software on the Cytomics FC 500 Flow Cytometer. The system with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 allows for simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ T lymphocyte population percentages and absolute counts. The system also provides the CD4/CD8 ratio. The system with CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+ (T), CD19+ (B), and CD3-/CD56+ (NK) lymphocyte population percentages and absolute counts. The tetraCXP SYSTEM Software comprises two functions: an Auto-Set Panel and an Automated Analysis Algorithm. The Auto-Set Panel automatically standardizes the cytometer, adjusts compensation settings, passes cytometer settings to designated test protocols, and verifies cytometer setup and antibody performance. Compensation settings are determined using QuickCOMP 4 Cells. The Automated Analysis Algorithm works in conjunction with the tetraCHROME monoclonal antibodies to automatically identify and enumerate sample populations.

Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter CYTO-STAT® tetraCHROME™ reagents and tetraCXP SYSTEM, based on the provided document K121445:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a Special 510(k) submission for changes related to labeling claims for specimen and prepared sample stability. The specific acceptance criteria themselves are not explicitly detailed in the document. Instead, the study results simply state that these criteria were met.

Therefore, I will present the acceptance criteria based on what the study aimed to demonstrate (stability limits) and the reported performance as a confirmation of meeting those (unspecified) limits.

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

• Sample Size for Test Set: The document does not specify the sample size used for the stability studies. It only mentions "Specimens tested at various time intervals."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

This type of study (stability testing of flow cytometry reagents and system) does not typically involve human experts establishing "ground truth" in the same way, for example, a diagnostic imaging study would. The ground truth here is inherently defined by the physical stability of the biological samples and the accurate measurement capabilities of the flow cytometer and its software.

Therefore, the concepts of "number of experts" and "qualifications of those experts" for establishing ground truth are not applicable in this context. The "ground truth" would be established by the validated methods of measuring cell populations over time, using predicate devices or established laboratory techniques as a reference.

4. Adjudication Method for the Test Set

Since human expert assessment and "ground truth" in the interpretive sense are not relevant for this type of stability study, an adjudication method is not applicable. The results are quantitative measurements from a machine and are assessed against predefined performance metrics.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for this submission. This type of study is typically relevant for evaluating the impact of an AI system on human interpretive performance, which is not the subject of this 510(k) special submission. The submission focuses on the stability of specimens and prepared samples when used with the reagents and system.

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

The tetraCXP SYSTEM with its Automated Analysis Algorithm does operate in a "standalone" fashion for identifying and enumerating cell populations. The submission states: "The Automated Analysis Algorithm works in conjunction with the tetraCHROME monoclonal antibodies to automatically identify and enumerate sample populations."

However, the specific "study that proves the device meets the acceptance criteria" in this Special 510(k) is about specimen and prepared sample stability when used with the system. While the system has an automated algorithm, this submission is not presenting new standalone performance data for the algorithm itself, but rather validating the stability claims. The original performance of the automated algorithm was cleared under predicate devices (K030828 for the tetraCXP SYSTEM).

7. Type of Ground Truth Used

For the stability studies, the "ground truth" would have been established by performing measurements at baseline (Time 0) and then comparing subsequent measurements at various time intervals to these baseline values. The "ground truth" for the cell population enumeration itself (CD3+, CD4+, etc.) is based on the known specific binding of the monoclonal antibodies to their respective antigens and the accurate detection by the flow cytometer, often correlated with established manual gating procedures or validated reference methods.

In essence, the ground truth for stability is the initial measurement, and the acceptance criteria define the allowable deviation from this initial measurement over time.

8. Sample Size for the Training Set

This submission is a Special 510(k) for changes to labeling claims regarding sample stability, not for the development or re-evaluation of the automated analysis algorithm itself. Therefore, information regarding the sample size for the training set for the tetraCXP SYSTEM's algorithm is not provided in this document. This data would have been part of the original 510(k) submission for the tetraCXP SYSTEM (K030828).

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

Similar to point 8, this information pertains to the original development of the tetraCXP SYSTEM's automated algorithm, not this specific Special 510(k) submission. Therefore, the document does not provide details on how the ground truth for the training set of the automated algorithm was established. It is highly probable that the ground truth for algorithm training would have involved expert-gated flow cytometry data serving as the reference for various lymphocyte populations observed.

Ask a specific question about this device