(14 days)
Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.
Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.
The provided text describes the Para® 5X hematology control device, but it lacks specific acceptance criteria (numerical thresholds for performance) and detailed study results that would allow for a comprehensive table of acceptance criteria vs. device performance. The document generally states that "All testing showed that Para 5X is consistently reproducible and performs within the claims."
However, based on the available information, here is an attempt to address the request as best as possible, with significant limitations due to the lack of explicit numerical data in the provided text.
Acceptance Criteria and Study Details for Para® 5X
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., CV% thresholds, bias limits) are not explicitly stated in the provided text, the table below uses descriptive terms based on the general conclusions presented. The reported performance is also described in general terms for the same reason.
| Performance Metric/Test | Acceptance Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Consistent and reproducible performance throughout claimed open vial period | Consistently reproducible and performs within claims |
| Long-Term Stability (Shelf Life) | Consistent and reproducible performance throughout claimed shelf life period | Consistently reproducible and performs within claims |
| Alternate/Off-Site Testing | Consistent and reproducible performance in various testing environments | Consistently reproducible and performs within claims |
| Baso % and # addition | Stable and accurate Basophil information integration and measurement for ABX Pentra 60 C+ and Beckman Coulter AcT analyzers | Provides stable Baso information; Consistently reproducible and performs within claims |
| Overall Performance | Safe and effective for controlling counting procedures, performing as claimed | Safe and effective; performs as claimed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the "Open Vial Stability," "Long-Term Stability (Shelf Life)," or "Alternate/Off-Site Testing" studies. It generally refers to "Studies" being conducted.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given the nature of stability and performance testing for a control product, it is most likely a prospective study conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable to this type of device (hematology quality control material). Ground truth for control materials is typically established through extensive characterization and validation using reference methods and statistical analysis within the manufacturer's own quality control processes, rather than by human expert consensus or pathology reports on patient samples.
4. Adjudication Method for the Test Set
This section is not applicable. Since the device is a quality control material whose performance is measured against internal specifications and established reference instrument values, an adjudication method for reconciling expert opinions is not relevant.
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 relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. Para® 5X is a quality control material, not an AI-based diagnostic tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, the testing described for Para® 5X represents a "standalone" assessment of the control material's performance. The device itself (the control material) is evaluated for its inherent stability and reproducibility on the specified hematology analyzers, independent of human interpretation of patient results. The studies focused on the performance of the control material when processed by the automated analyzers.
7. The Type of Ground Truth Used
The "ground truth" for Para® 5X (a hematology control) would be based on:
- Reference Instrument Measurements: Expected values for CBC/Diff parameters are established by running the control material on validated reference analyzers.
- Methodology-Specific Characterization: Extensive characterization on the target analyzers (ABX Pentra 60 C+ and Beckman Coulter™ AcT™) to establish assay values and acceptable ranges.
- Statistical Analysis: Rigorous statistical methods are used to determine limits for stability, precision, and accuracy, ensuring the material meets its intended quality control function.
- Manufacturing Specifications: The product's formulation and stabilization processes are designed to achieve specific biological properties, which serve as the intrinsic "truth" the control is designed to maintain.
8. The Sample Size for the Training Set
This section is not applicable. Para® 5X is a physical quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development involves chemical and biological formulation, stability studies, and performance characterization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
§ 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.