(29 days)
R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to assay sheet for specific instrument models.
This control is a hematology control mixture designed to monitor values obtained from Sysmex hematology instruments.
The provided text describes a 510(k) premarket notification for the "R&D CBC-XE Hematology Control" device. This device is a hematology quality control mixture, not an AI/ML-driven diagnostic device, thus many of the requested categories are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the product life | "R&D CBC-XE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Precision | "R&D CBC-XE Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing." (Specific values are not provided in this summary but are implied to be acceptable.) |
| Stability (Expiration Dating) | Established at 75 days (closed vial) and 14 days, or 14 samplings (open vial) when stored at 2 - 8° C and handled according to instructions for use. |
| Substantial Equivalence to Predicate Device | "Laboratory testing of 3 validation lots has shown R&D CBC-XE Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "3 validation lots" were tested. The exact number of individual measurements or samples within these lots is not specified.
- Data Provenance: The data appears to be generated internally by R&D Systems, Inc. through "laboratory testing." No information on the country of origin or whether it's retrospective or prospective is provided, but typically such validation is prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This device is a quality control material for hematology instruments, not a diagnostic device that requires expert interpretation for a "ground truth" related to disease states. Its performance is measured against reference values and precision targets, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
- Not Applicable: As stated above, this device does not involve human interpretation or adjudication for its performance assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: This type of study is relevant for diagnostic devices that are interpreted by human readers, often with AI assistance. It is not applicable to an automated hematology control.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes (Implicitly): The "performance, precision, and stability" of the hematology control itself are evaluated directly through laboratory testing using Sysmex hematology instruments. This is inherently a standalone evaluation of the control material's properties. There is no "human-in-the-loop" component in assessing the control material's values.
7. The Type of Ground Truth Used
- Reference Values / Expected Ranges / Precision Targets: For a hematology control, the "ground truth" for each parameter (e.g., cell counts, hemoglobin) would be established by the manufacturer and validated through rigorous testing against reference methods or highly precise internal standards. The summary indicates the device's acceptable performance within "assay ranges" and demonstrates "small standard deviation and % CV's," implying a comparison to known, expected values and precision limits.
8. The Sample Size for the Training Set
- Not Applicable: This device is a physical control material and not an AI/ML algorithm that undergoes "training." Its development and formulation would involve extensive R&D and manufacturing processes, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As explained above, there is no training set for this type of 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.