(72 days)
ABX Erytrol is a tri-level control design for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for the nucleated red blood cell count (NRBC parameter). Refer to the assay table for specific instrument models.
The ABX Erytrol is an in-vitro diagnostic blood control composed of human erythrocytes & mammalian leukocytes in a plasma-like fluid with preservatives. The ABX Erytrol is composed of stable materials that provide a means of monitoring the performance of ABX hematology analyzers offering the nucleated red blood cell count (NRBC) parameter.
Here's a breakdown of the acceptance criteria and study information for the ABX ERYTROL device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product (stability) | ABX Erytrol stayed within the assay range. Expiration dating established at 60 days in customer's hands (closed vial) and 10 days or 12 entries (open vial) when stored at 2-8°C and handled according to instructions. |
| Precision (demonstrated by small standard deviations and % CV) | ABX Erytrol demonstrated precision as indicated by the small standard deviations and % CV obtained during testing. |
Study Details
- Sample size used for the test set and the data provenance: Not explicitly stated. The study refers to "3 validation lots." The country of origin for the data is France, where the company Horiba ABX is located. The study appears to be non-clinical, likely laboratory-based testing rather than clinical trials with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not stated. As this is a quality control material rather than a diagnostic device that interprets patient data, expert review for ground truth isn't relevant in the traditional sense. The "ground truth" for a quality control material is its expected assay range and stability performance, which is determined by the manufacturer's internal testing and specifications.
- Adjudication method for the test set: Not applicable/not stated.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not applicable for a hematology quality control mixture.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the testing described appears to be standalone performance testing of the quality control material itself and its interaction with ABX hematology analyzers.
- The type of ground truth used: Manufacturer's internal specifications and expected performance characteristics for stability and precision against an assay range. This is derived from thorough development and testing of the control material.
- The sample size for the training set: Not applicable/not stated. For a quality control mixture, there isn't a "training set" in the machine learning sense. The formulation and initial characterization of the control would involve extensive developmental testing, but specific "training set" sizes are not relevant here.
- How the ground truth for the training set was established: Not applicable/not stated for a "training set." The performance characteristics (e.g., assay range, expected stability, precision limits) are established through extensive R&D and manufacturing processes, including characterization of the components and the final product's behavior over time and under various conditions.
§ 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.