(39 days)
R&D CBC-3D + CRP Hematology Control is a tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers. It can also be used for manual methods.Refer to assay sheet for specific instrument models.
This control is a tri-level control to monitor values on automated and semiautomated impedence type hematology analyzers. It can also be used for manual methods.
Here's an analysis of the provided text regarding the R&D CBC-3D + CRP Hematology Control, addressing your requested 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-3D + CRP Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Precision (demonstrated by small standard deviation and % CVs) | "R&D CBC-3D + CRP Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing." |
| Stability (closed vial) | "Expiriation dating has been established at 105 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use." (Implies meeting stability criteria for this duration) |
| Stability (open vial) | "Expiriation dating has been established at... 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use." (Implies meeting stability criteria for this duration) |
| Substantial equivalence in performance | "Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in performance... to the predicate device [R&D Systems CBC-3D Hematology Control, K843962]." |
| Substantial equivalence in precision | "Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in... precision... to the predicate device [R&D Systems CBC-3D Hematology Control, K843962]." |
| Substantial equivalence in stability | "Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in... stability to the predicate device [R&D Systems CBC-3D Hematology Control, K843962]." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "3 validation lots" were tested. No further breakdown of the number of individual tests or samples within these lots is provided.
- Data Provenance: The study was conducted through "Laboratory testing," implying an internal validation study by R&D Systems, Inc. The country of origin of the data is not explicitly stated but is implicitly the USA, where the company is located. The study is prospective in nature, as it involves testing new validation lots before market release to establish performance and stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a hematology quality control mixture, the "ground truth" would likely be established by the manufacturing specifications and reference methods, not by human experts in the way image analysis or clinical diagnosis might require.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a quality control product, adjudication by multiple experts is unlikely to be a relevant method. The "ground truth" (or target range) for such a device is typically defined by the assay sheet and manufacturing specifications rather than expert consensus on individual results.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for a hematology quality control mixture, which is not an AI-powered diagnostic device but rather a calibration and quality assurance tool for laboratory instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study, as typically understood for an AI algorithm, was not done. This device is a consumable for instruments, not an algorithm itself. The performance assessment was of the control mixture's ability to maintain its specified values over time and across different lots, in comparison to a predicate device.
7. The Type of Ground Truth Used
The ground truth used for this device would be the established assay ranges and target values as per the manufacturer's specifications for the control material, and the expected performance characteristics based on the predicate device. This is implicitly derived from established reference methods for hematology parameters. It's not "expert consensus," "pathology," or "outcomes data" in the typical sense.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is a physical diagnostic control, not an AI model requiring a training set. The "training" for such a product involves its formulation and manufacturing process development, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above. The "ground truth" in the context of developing such a control would be the desired target values for the hematology parameters and the stability characteristics determined through extensive R&D and calibration against reference materials and methods.
§ 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.