(39 days)
R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.
R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.
The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.
The provided document is a 510(k) summary for the R&D Glucose/Hemoglobin™ Whole Blood Control, a device used for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin. As such, it is a control solution used to validate other medical devices, not a diagnostic or prognostic device that itself interprets patient data. Therefore, many of the typical acceptance criteria and study components requested in the prompt, which are usually applicable to diagnostic algorithms or medical imaging devices (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details), are not relevant or present in this context.
However, based on the information available, here's a summary tailored to the nature of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product | Met: Stability established for 205 days (closed vial) and 30 days (open vial) when stored at 2-8°C. Met: Open vial stability of 7 days at ambient temperature. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the traditional sense for a control solution. The "test set" here refers to the actual R&D Glucose/Hemoglobin™ Whole Blood Control product itself, which was tested for its performance attributes.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective for a control solution's performance testing. The testing was conducted by R&D Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for a control solution isn't established by expert consensus on patient data. Instead, the "truth" is its assayed value, which would be determined through validated laboratory methods and measurements against reference standards, not expert interpretation.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among human reviewers of patient data, which is not relevant for a control solution.
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
- Not applicable. This device is a control solution, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a biochemical control solution, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device is its assayed value for glucose and hemoglobin, which is intrinsically determined during its manufacture and verified through laboratory testing. This is analogous to a certified reference material, where the "truth" is established by its chemical composition and precise measurements, not by expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The sample size for the training set
- Not applicable. This device is a control solution, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See 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.