(71 days)
R&D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations.
This control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.
The information provided describes the R&D Systems, Inc. GLU-LINE Hematology Control, a device designed to measure the linearity of glucose analyzers.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remains within assay range over product life | Passed the acceptance criteria of remaining within the assay range over the life of the product. |
| Stability | Expiration dating established at 105 days (closed vial) when stored at 2-8°C and handled according to instructions for use. |
| Precision | Demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. |
| Substantial Equivalence to Predicate Device | Laboratory testing of 3 validation lots has shown R&D GLU-LINE Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device (R&D Systems Glucose Hemoglobin Hematology Control, K993321). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The submission states that 3 validation lots were tested. The specific number of individual samples or measurements within those lots is not provided.
- Data Provenance: The data was generated through "Laboratory testing" and is therefore prospective as it was conducted specifically for the validation of this device. The country of origin is not explicitly stated but can be inferred as the United States, given the company's address in Minneapolis, MN, and the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/ not provided in the context of this device. The GLU-LINE Hematology Control is a quality control material intended to assess the performance of glucose analyzers by providing known glucose levels. The "ground truth" for such a device would be the precisely manufactured and calibrated glucose values within the control material itself, not established by human experts interpreting clinical data. Therefore, there's no mention of experts establishing ground truth for the test set in the biological sense. The truth is intrinsic to the product design and manufacturing.
4. Adjudication method for the test set
This information is not applicable / not provided. As explained above, for a quality control material with precisely defined glucose levels, there is no need for expert adjudication of results. The device's performance is assessed against its own intended specifications and its comparison to a predicate device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The GLU-LINE Hematology Control is a quality control material; its direct interaction is with an automated instrument, not human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the context of this device. The GLU-LINE Hematology Control itself is an inert control material; it doesn't have an "algorithm" in the sense of an AI software. Its performance is measured by how accurately and precisely glucose analyzers read the known glucose concentrations within the control. The study assesses the performance of the control material, not a standalone algorithm.
7. The type of ground truth used
The ground truth for this device is the known, manufactured concentrations of glucose within the control material. These concentrations are established during the product's formulation and manufacturing process, likely through highly precise analytical methods and calibration. The device's performance is then evaluated by how well external analyzers measure these known concentrations.
8. The sample size for the training set
This information is not applicable / not provided. The GLU-LINE Hematology Control is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI development.
9. How the ground truth for the training set was established
This information is not applicable / not provided for the same reasons as point 8.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.