(53 days)
CSF AUTOMATED CONTROL is an assayed whole blood control designed to monitor values obtained using hematology instruments that measure CSF samples. Refer to the assay table for specific instrument models.
CSF AUTOMATED CONTROLS is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples. For in vitro Diagnostic Use Only
CSF AUTOMATED CONTROL is an in vitro diagnostic reagent composed of human erythrocytes and bovine leukocytes suspended in a cerebrospinal like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained using hematology instruments that measure CSF (cerebral spinal fluid) samples. It is sampled in the same manner as a patient specimen.
The provided text describes a medical device, the "CSF AUTOMATED CONTROL," which is an in vitro diagnostic reagent used as a hematology control. The document focuses on demonstrating its substantial equivalence to a predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the stated life of the product. | The CSF Automated Hematology Control passed the acceptance criteria of remaining within the assay range over the stated life of the product. |
| Substantial equivalence in performance, precision, and stability to the predicate device. | Laboratory testing of 3 validation lots has shown the CSF AUTOMATED CONTROL to have substantial equivalence in performance, precision, and stability to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Laboratory testing of 3 validation lots has shown the CSF AUTOMATED CONTROL to have substantial equivalence..." However, it does not specify the sample size within these lots (i.e., how many individual control samples were tested, or how many measurements were taken from each lot).
The data provenance is presented as "laboratory testing," implying it was conducted under controlled conditions, likely by the manufacturer R&D Systems, Inc. There is no information provided regarding the country of origin of the data, nor whether it was retrospective or prospective. Given the nature of a control reagent, it would typically involve prospective testing in a lab setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The CSF AUTOMATED CONTROL is a quality control reagent designed to monitor the performance of hematology instruments. Its "ground truth" is its own established assay range and its consistency, not a diagnostic interpretation that would require expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods are relevant for studies where human interpretation or diagnosis is being evaluated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not conducted and is not applicable here. This device is a quality control reagent, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable in the context of this device. The CSF AUTOMATED CONTROL is a physical reagent. Its "performance" is its ability to consistently produce results within a defined range when run on an instrument, not an algorithm's output. The study described focuses on the intrinsic properties of the reagent (performance, precision, stability) relative to a predicate.
7. Type of Ground Truth Used
The "ground truth" for this device is its established assay range and its inherent stability, precision, and performance characteristics. This is determined through internal laboratory testing and characterization of the control material itself, rather than expert consensus, pathology, or outcomes data, which are relevant for diagnostic devices.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this physical control reagent. Training sets are used for machine learning algorithms. The study involved "3 validation lots," which served as the test material, not a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set in the context of this device, this question is not applicable. The "ground truth" for the behavior of the control (its assay range) would have been established through extensive characterization by the manufacturer during its development and manufacturing process, independent of this specific substantial equivalence study.
§ 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.