(168 days)
R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.
For in vitro Diagnostic Use Only
The R&D Systems Retic-I Plus Hematology Control is an in vitro diagnostic reagent composed of human and avian erythrocytes in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring automated reticulocyte counting method. It is sampled in the same manner as a patient specimen.
Here's an analysis of the provided text regarding the R&D Systems Retic-I Plus Hematology Control, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Remaining within assay range over product life | "The Retic-I Plus Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Expiration dating (closed vial) | Established at 75 days when stored at 2 - 8° C. |
| Expiration dating (open vial) | Established at 14 days when stored at 2 - 8° C. |
| Performance | "substantial equivalence in performance... to the predicate device." |
| Precision | "substantial equivalence in... precision... to the predicate device." |
| Stability | "substantial equivalence in... stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Laboratory testing of 3 validation lots has shown..." This indicates a test set size of 3 lots of the Retic-I Plus Hematology Control.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the nature of device validation testing generally implies a prospective study design where the device is tested under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study appears to be a laboratory validation of a control material against a predicate device, rather than a clinical study requiring expert assessment of individual cases. The ground truth for a hematology control would typically be established by precise measurements using well-calibrated reference methods or instruments, not by human expert consensus on specific cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved. This study focuses on the performance, precision, and stability of a laboratory control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. The document describes a laboratory validation study comparing the new control material's performance to a predicate device, not a human reader study evaluating the effectiveness of AI assistance.
- Effect size of human reader improvement with AI vs. without AI assistance: This information is not applicable as an MRMC study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done?: Yes, in essence. The study described focuses on the inherent performance of the Retic-I Plus Hematology Control as a standalone product. While it's not an "algorithm" in the typical AI sense, the control material itself is the "device" being evaluated for its performance characteristics (stability, precision, staying within assay range) independent of human interpretation of individual patient samples. The performance described ("remaining within the assay range over the life of the product," "substantial equivalence in performance, precision and stability") refers to the intrinsic behavior of the control.
7. Type of Ground Truth Used
The ground truth used for this device appears to be based on:
- Assay Range: The acceptable range of values for reticulocyte counts that the control should maintain. These ranges would likely be established through rigorous laboratory testing on reference instruments or methods.
- Predicate Device Performance: The established, known performance (stability, precision) of the legally marketed predicate device (R&D Systems Advia Retic Plus Hematology Control). The new device's performance is compared against this established benchmark to demonstrate "substantial equivalence."
8. Sample Size for the Training Set
This information is not provided and is not applicable for this type of device. Hematology control materials are not "trained" in the way an AI algorithm is trained. Their performance characteristics are inherent to their formulation and manufacturing process, which are then validated through testing.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for this type of device, as there is no "training set" in the context of an AI algorithm learning from data. The properties of the control material (e.g., stability, assay range) are determined intrinsically and validated experimentally.
§ 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.