(21 days)
R&D XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers. For in vitro Diagnostic Use Only
The R&D Systems XERet Hematology Control is an in vitro diagnostic reagent composed of human and porcine cells in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
The provided text describes the acceptance criteria and the study for the R&D XERet Hematology Control. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within range over the life of the product | Passed this criterion. |
| Substantial equivalence in performance, precision, and stability to the predicate device | Demonstrated substantial equivalence in these aspects. |
| Closed vial expiration dating | Established at 85 days when stored at 2 - 8° C. |
| Open vial expiration dating | Established at 15 days when stored at 2 - 8° C and handled per instructions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Laboratory testing of 3 validation lots" was performed.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location (Minneapolis, MN, USA) and the submission to the FDA, it's highly likely the data is from the USA and is prospective as it's part of a validation study for a new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The "ground truth" for a hematology control typically refers to the expected range of values for given parameters, which are often established through rigorous internal testing and statistical analysis by the manufacturer, rather than by external expert consensus in the same way, for example, a diagnostic image might be.
4. Adjudication Method for the Test Set
- This information is not explicitly stated. Given the nature of a hematology control (monitoring quantitative values), adjudication by multiple experts in the traditional sense (e.g., 2+1, 3+1) is typically not applicable. The performance is assessed against predefined statistical ranges and comparisons to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved, such as medical imaging. The R&D XERet Hematology Control is an in vitro diagnostic reagent used to monitor automated hematology analyzers, not directly interpreted by human readers in the same context as an MRMC study.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, performance evaluation was done for the device itself. The device is a "control" for an analyzer, so its "standalone" performance relates to its ability to maintain stable and accurate assay values over time (stability, precision) and perform comparably to its predicate. The text states: "Laboratory testing of 3 validation lots has shown the R&D XERet Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device."
7. The Type of Ground Truth Used
- The ground truth for a hematology control is established by determining its assayed values and expected ranges for the measured parameters (RBC, RET%, RET#, IRF). This is typically done through a process of:
- Manufacturer's internal testing: Extensive testing of multiple lots to establish mean values and standard deviations for each parameter.
- Comparison to a predicate device: The study explicitly mentions "substantial equivalence... to the predicate device," implying the predicate's established performance serves as a reference point for acceptable ranges.
- Statistical analysis: To define the "range" within which the control should perform.
- Therefore, the ground truth is primarily based on established reference values/ranges derived from the manufacturer's testing and comparison to a legally marketed predicate device.
8. The Sample Size for the Training Set
- The document does not provide information regarding a training set. Hematology controls are manufactured to specific specifications and then
validated; they are not "trained" in the typical machine learning sense. The "3 validation lots" are part of the testing/validation phase.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable or mentioned for this device, a method for establishing its ground truth is also not provided.
§ 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.