(97 days)
HC WBC Control is an assayed whole blood control designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood. Refer to the assay table for specific instrument models.
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The HC WBC Hematology Control is designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood.
The HC WBC Hematology Control is an in vitro diagnostic control composed of human erythrocytes and bovine leukocytes in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood. It is sampled in the same manner as a patient specimen.
This document describes the HC WBC Hematology Control, an in vitro diagnostic control used to monitor white blood cell counts.
Here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the stated life of the product (stability) | Passed the acceptance criteria of remaining within the assay range over the stated life of the product. |
| Precision (standard deviation and % CV) | Demonstrated precision as indicated by the standard deviation and % CV's obtained during laboratory testing. |
| Substantial equivalence in performance to the predicate device | Achieved substantial equivalence to the legally marketed predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The study utilized "3 validation lots" of the HC WBC Hematology Control. The specific number of individual test samples within these lots is not provided.
- Data Provenance: The testing was conducted as "Laboratory testing," indicating it was likely performed in a controlled laboratory environment by the manufacturer (R&D Systems, Inc.). No information is provided regarding the country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a hematology control, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for a control material is typically its known, established target values and acceptable ranges.
4. Adjudication method for the test set:
This information is not applicable as the device is a hematology control. Adjudication methods like 2+1 or 3+1 are used for human expert review of diagnostic cases, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable as the device is a hematology control and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a hematology control used for quality control of analytical instruments, not a standalone diagnostic algorithm.
7. The type of ground truth used:
The ground truth for this device would be the known, established target values and acceptable ranges for white blood cell counts that the control product is designed to represent and monitor. These values are determined during the manufacturing and characterization of the control material according to established laboratory and quality control standards.
8. The sample size for the training set:
This information is not applicable. Hematology controls are manufactured to specific specifications and then validated. They are not "trained" in the machine learning sense. The "3 validation lots" mentioned are for performance testing, not training.
9. How the ground truth for the training set was established:
This information is not applicable. As mentioned above, hematology controls do not have a "training set" in the context of machine learning. The "ground truth" for the control material itself (i.e., its expected WBC count and range) is established during its manufacturing process, likely through highly precise reference methods and extensive testing, to ensure its accuracy as a control.
§ 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.