(60 days)
R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the linearity of automated hematology analyzers for reticulocyte parameter determinations.
R&D RET-LINE is a multi-level suspension of human erythrocytes and mammalian erythrocytes suspended in a simulated plasma fluid with preservatives packaged in a glass vial with a silicon rubber closure containing 3.0 mL of reagent.
The provided text describes the 510(k) summary for the R&D RET-LINE kit, a hematology quality control mixture, and its nonclinical testing. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within assay ranges over product life | Passed: R&D RET-LINE remained within assay ranges over the life of the product. |
| Meeting linearity specifications | Passed: R&D RET-LINE met linearity specifications. |
| Expiration dating (closed vial) | Established at 75 days (closed vial) when stored at 2 - 8 °C. |
| Open vial stability | No open vial stability claim (intended for single use and discard). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Nonclinical testing of three validation lots" was conducted. The specific number of individual samples or measurements within those lots is not detailed.
- Data Provenance: The data is from "nonclinical testing" performed by R&D Systems, Inc. There is no information regarding the country of origin of the data beyond the manufacturer's location in Minneapolis, MN, USA. The testing is implied to be prospective for product validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study focuses on the performance of a linearity control, and the "ground truth" for such a device is typically established by the manufacturer through rigorous characterization of the control material itself, rather than expert interpretation of patient samples.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided in the document. The testing describes the performance of a quality control material against pre-defined specifications (assay ranges, linearity), not a diagnostic device requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices whose performance depends on human interpretation, which is not the case for a linearity control.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable in the context of this device. The R&D RET-LINE is a physical control material used to assess the linearity of automated hematology analyzers, not an algorithm or software. The "standalone" performance refers to the control material's inherent stability and linearity characteristics when measured by the target hematology analyzers.
7. The Type of Ground Truth Used
- The "ground truth" for this device is the inherent characteristics of the control material itself, specifically its stability (remaining within assay ranges) and linearity. These are established by the manufacturer through laboratory assays and characterization of the material. It's not based on expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. This device is a quality control material, not an AI or machine learning algorithm that requires a "training set." The described testing is for validation of the control material itself.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable. As mentioned above, there is no "training set" for this type of device. The ground truth (stability and linearity) for the control material is established through internal scientific and manufacturing processes by the device 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.