(224 days)
ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.
The ABX Pentra Micro ALB Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with added chemicals, constituents of human origin, stabilizers and preservatives. The assigned values and precise confidence interval are given in an enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the HORIBA clinical chemistry analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the ABX Pentra Micro ALB Control L/H, a quality control material used to monitor the performance of Microalbumin determination. The study described focuses on establishing the stability claims of this control rather than evaluating the performance of a diagnostic device in detecting a medical condition. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to this type of device and study.
Here's an analysis of the provided information concerning 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 |
|---|---|
| Shelf Life | 24 months at 2 to 8°C |
| Open Vial Stability | 90 days at 2 to 8°C |
| Performance Monitoring (Intended Use) | Monitors the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry. |
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: Not explicitly stated as a separate "test set" for an accuracy study. The stability studies (shelf life and open vial) would inherently involve testing multiple aliquots over time following specific protocols. The number of samples/replicates used in these stability studies is not detailed.
- Data Provenance: The study was conducted by HORIBA ABX SAS, located in Montpellier, France. The data appears to be prospective, collected for the purpose of demonstrating stability claims.
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 is not applicable as the device is a quality control material and the study focuses on its stability. "Ground truth" in the context of diagnostic accuracy (e.g., pathology, clinical outcomes) is not relevant here. The "ground truth" for a control material involves its assigned values, which are determined internally by the manufacturer through rigorous calibration and value assignment processes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the study is not evaluating a diagnostic device's performance against a clinical ground truth.
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
This is not applicable. This is a quality control material, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a quality control material; there is no algorithm or human-in-the-loop performance to evaluate in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this control material is its assigned values and corresponding ±3SD confidence ranges, which are determined by the manufacturer (HORIBA ABX SAS) by calculating the mean value obtained from multiple determinations. This is a form of internal validation and characterization of the control material's expected performance.
8. The sample size for the training set
This is not applicable. This is a quality control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.