(208 days)
6C 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.
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.
6C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium. 6C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes and nucleated red blood cells. By design, 6C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination, NRBC enumeration and White Blood Cell differentiation using VCSn technology.
The provided text describes a 510(k) submission for the COULTER® 6C Cell Control, a hematology quality control material. It primarily focuses on the device's description, intended use, and comparison to predicate devices, along with the FDA's clearance letter. However, the document does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria values, a formal study report with detailed performance metrics, sample sizes for test sets, expert qualifications, or MRMC comparative effectiveness studies.
Based on the information available in the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., specific ranges for recovery, precision targets). It generally states that the device is used to "monitor instrument accuracy and precision performance" and that "assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance."
The primary performance data reported is related to stability:
| Performance Metric | Acceptance Criteria (Inferred from reported data) | Reported Device Performance |
|---|---|---|
| Stability (Open Vial) | To support 18 days of stability | 18 days |
| Stability (Closed Vial) | To support 95 days of stability | 95 days |
Note: The document states, "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution." However, it does not provide the specific data points that demonstrate this. The stability data is the only concrete performance metric mentioned in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are "Stability studies," but details about the number of runs, samples, or instruments involved are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. For a quality control material, the "ground truth" would likely be established through reference methods or highly calibrated instruments, rather than expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable for a quality control material where performance is assessed against established targets or reference values, rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or mentioned. This type of study is more relevant for diagnostic imaging or interpretation devices where human readers are involved. The 6C Cell Control is a quality control material used to monitor instrument performance.
6. Standalone Performance Study
The "Summary of Performance Data" refers to "Stability studies." These studies would be considered standalone performance assessments of the control material itself, demonstrating its ability to maintain stable parameters over time. However, the details of these studies are not provided in this document. The device's primary function is to monitor the performance of an analyzer, so its "standalone" performance relates to its internal stability.
7. Type of Ground Truth Used
For a quality control material like the COULTER® 6C Cell Control, the ground truth for parameters like cell counts, sizing, and hemoglobin would most likely be established through:
- Reference Methods: Highly accurate, often manual or specialized, laboratory methods.
- Assigned Values: Values derived from extensive testing on reference instruments, often by the manufacturer, and subsequently printed on the product's "TABLE OF EXPECTED RESULTS."
- Calibration Standards: Traceability to primary calibration standards.
The document states, "The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance." This implies that the "ground truth" for the device's expected values is based on these assigned values.
8. Sample Size for the Training Set
The document does not mention a "training set." This concept is typically applicable to AI/machine learning models. The 6C Cell Control is a physical control material, not a software algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device and confirming basic stability. It does not contain the detailed study reports or performance data that would typically be found in a full scientific publication or a more comprehensive regulatory submission for a novel diagnostic device.
§ 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.