(260 days)
4C®EX 300 Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your instrument specific instructions for use).
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.
4C -EX 300 Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium. 4C®-EX 300 Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 4C®-EX 300 Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing and hemoglobin determination.
This document describes the COULTER® 4C®-EX 300 Cell Control, a hematology quality control material.
The stated intended use is to "monitor the performance of COULTER® hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents."
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., maximum allowable deviation, coefficient of variation). Instead, the performance studies assess the stability and the process for establishing expected values.
| Study | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|
| Open and Closed Vial Stability | Maintain stable performance over the product's shelf life on specified instruments (DxH 300 and DxH 300C). | Demonstrated acceptable results. |
| Value Assignment Process | Establish a robust and validated process for determining assigned values for each lot. | Established process for generating assigned value for 4C®-EX 300 Cell Control. |
| Range Determination Process | Establish a statistically sound method to calculate RDW-SD expected ranges based on existing parameters and their mathematical relationship. | Established RDW-SD expected ranges for each level of 4C®-EX 300 Cell Control. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document specifies "3 lots" for the open and closed vial stability study. It does not provide specific sample sizes (e.g., number of vials, number of runs) beyond this. The "Value Assignment Process" and "Range Determination Process" studies describe methodology rather than specific sample sizes of actual test runs.
- Data Provenance: The data is generated by Beckman Coulter, Inc. as part of their 510(k) submission for regulatory approval. The studies were conducted internally. There is no information regarding country of origin for the data or if it was retrospective or prospective, though internal studies for regulatory submission are typically prospective for the specific purpose of the submission.
3. Number of Experts to Establish Ground Truth and Qualifications
- Number of Experts: The document mentions "multiple analysis of the control product" for value assignment and a "bio-statistician" for range determination. It does not specify the exact number of experts (e.g., laboratory technicians, statisticians) or their specific qualifications (e.g., years of experience, certifications) beyond those functional roles.
- Qualifications of Experts:
- For Value Assignment: Implied to be individuals trained and qualified to perform analysis on validated hematology systems using specific Beckman Coulter reagents.
- For Range Determination: A "bio-statistician" is explicitly mentioned, implying expertise in statistical analysis relevant to biological measurements.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The studies focus on internal validation of the control material's stability, value assignment, and range determination. There is no mention of external reviewers or a process for resolving discrepancies in results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC comparative effectiveness) is typically associated with diagnostic algorithms or imaging devices where human readers interpret results with and without AI assistance to assess changes in diagnostic accuracy or efficiency. The COULTER® 4C®-EX 300 Cell Control is a quality control material, not a diagnostic algorithm, and therefore such a study is not applicable to its evaluation.
6. Standalone Performance Study
Yes, in a sense relevant to a quality control material. The "Open and Closed Vial Stability" study, "Value Assignment Process," and "Range Determination Process" evaluate the performance of the control material itself (standalone) in its intended function. These studies assess the inherent characteristics and consistency of the control without direct human interpretation being the primary variable.
7. Type of Ground Truth Used
The ground truth for this quality control material is established through:
- Reference Method / Assigned Values: For the "Value Assignment Process," the document states, "Value assignments for each lot of 4C®-EX 300 Cell Control are determined on validated systems using specific Beckman Coulter reagents." This implies that the 'ground truth' for the assigned values is derived from precise measurements on highly controlled and validated reference instruments and methods.
- Statistical Derivation: For the "Range Determination Process," the ground truth for the RDW-SD ranges is established by a "bio-statistician" based on the "assigned values and expected ranges of MCV and RDW parameters and the mathematical relationship between these parameters."
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of an algorithm or AI. This product is a control material, not a machine learning model. The studies described are for validation of the control material's performance and the processes used to establish its characteristics, not for training an AI system.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. For the control material itself, the "ground truth" for its assigned values and ranges are established through the processes described in section 7 (e.g., validated instrument measurements, statistical derivation).
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.