(107 days)
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
For in vitro Diagnostic Use Only.
The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
The provided document describes the R&D 5D Retic Hematology Control, an in vitro diagnostic reagent used to monitor reticulocyte counting methods on Coulter® hematology analyzers. The submission is a 510(k) for substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in performance to predicate device | Laboratory testing of 3 validation lots showed substantial equivalence in performance to the predicate device. |
| Substantial equivalence in precision to predicate device | Laboratory testing of 3 validation lots showed substantial equivalence in precision to the predicate device. |
| Substantial equivalence in stability to predicate device | Laboratory testing of 3 validation lots showed substantial equivalence in stability to the predicate device. |
| Remaining within range over the life of the product | The R&D 5D Retic Hematology Control passed the acceptance criteria of remaining within range over the life of the product. |
| Established expiration dating | Expiration dating will be established at 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructions for use. (This is a result of the stability testing that met the previous criterion). |
Study Details:
The study was a laboratory validation study comparing the R&D 5D Retic Hematology Control to its predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: "3 validation lots" were used. The document does not specify the number of individual vials or measurements within each lot.
- Data Provenance: The study was conducted by R&D Systems, Inc. in Minneapolis, MN, USA. The data would be considered prospective, as it was generated specifically for this 510(k) submission to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This device is a quality control material for hematology analyzers, not a diagnostic imaging or interpretive device that requires human expert opinion for ground truth. The "ground truth" for a quality control material is its expected range of values when tested on specified instruments, which is typically established through extensive internal testing by the manufacturer using validated reference methods and statistical analysis. The document does not mention the involvement of external experts in establishing the ground truth ranges for the control material itself. The performance comparison is against a predicate device, implying that the predicate's established performance serves as a benchmark.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As this is a quality control material, there is no "ground truth" established by human adjudication in the traditional sense of diagnostic assessments. Performance is determined by instrumental readings and statistical comparison to established ranges and predicate device performance.
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 hematology control, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical control material. The "performance" is its ability to produce expected results on a hematology analyzer, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a hematology control is its pre-established assayed values and expected ranges for specific parameters (RET%, RET#, IRF, MRV) on designated hematology analyzers. These ranges are determined by the manufacturer through rigorous testing using calibrated instruments and reference methods. The study's aim was to demonstrate that the new control material performs substantially equivalently to the predicate device, meaning its values fall within comparable expected ranges or demonstrate similar precision and stability characteristics.
8. The sample size for the training set
Not applicable. This is a quality control material, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set." The performance characteristics and expected ranges of the control material are established through internal assay and validation processes by the manufacturer.
§ 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.