(27 days)
CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1 c determination methods.
The CONE-TROL Hemoglobin A 1c Control Set is prepared from human blood to which chemicals, preservatives, and stabilizers are added. The control is provided in liquid form for user convenience.
The provided documentation describes the acceptance criteria and study for the CONE-TROL Hemoglobin A1c Control Set, a quality control material, primarily focusing on its stability. It is not an AI/ML device, so many of the requested fields (e.g., MRMC studies, human reader improvement, multi-reader consensus) are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the CONE-TROL Hemoglobin A1c Control Set is that the analyte activity (concentration) must fall within ±10% of the initial value at various storage conditions and time points.
| Analyte | Acceptance Criteria (Concentration Range Accepted by Company) | Initial Value | Reported Performance (Concentration/Percent Change) at different conditions |
|---|---|---|---|
| Accelerated Closed Vial Stability (37°C, 30 hours) | |||
| HbA1c-Level 1 | 4.2-6.4% (implies ±10% around 5.3%) | 5.3% | 5.4% (1.89% change) |
| HbA1c-Level 2 | 8.6-13.0% (implies ±10% around 10.8%) | 10.8% | 10.8% (0% change) |
| Real Time Closed Vial Stability (-20°C, 210 days) | |||
| HbA1c-Level 1 | 4.2-6.4% (implies ±10% around 5.3%) | 5.3% | 5.4% (1.89% change) |
| HbA1c-Level 2 | 9.5-14.3% (implies ±10% around 11.9%) | 11.9% | 12.1% (1.68% change) |
| Open Vial Stability (2-8°C, 210 days) | |||
| HbA1c-Level 1 | 4.2-6.4% (implies ±10% around 5.3%) | 5.3% | 5.0% (5.7% change) |
| HbA1c-Level 2 | 9.5-14.3% (implies ±10% around 11.9%) | 11.9% | 11.5% (3.4% change) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For stability studies, the "sample" typically refers to the number of vials or batches tested. The document mentions two vials were assayed in triplicate for value assignment, and data points were collected over several days (minimum 6 data points per level for value assignment). For stability, specific numbers of individual vials tested at each time point are not explicitly stated, but it follows a standard protocol of testing representative aliquots from the prepared control sets.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies were conducted by the manufacturer, Cone Bioproducts, located in Seguin, TX, USA, for regulatory submission to the FDA. The stability studies are prospective, as they track the product over time.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a quality control material whose "truth" is its chemical concentration, determined by analytical instrumentation. It does not involve human interpretation or expert opinions to establish ground truth in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. Ground truth for this chemical control is established through objective analytical measurements, not through adjudication of expert opinions.
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
Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the performance of the control material is assessed in a "standalone" manner. Its stability and value assignment are determined purely through analytical measurements on laboratory instruments (Tosoh G7 HPLC Analyzer). There is no "human-in-the-loop" component in determining the performance of the control material itself; it's an objective measurement of its chemical properties over time.
7. The Type of Ground Truth Used
The ground truth used is the measured concentration of HbA1c in the control material, determined by objective analytical methods using the Tosoh G7 HPLC Analyzer. This is a form of measurement data/analytical truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device. The "ground truth" for the control material's initial value (value assignment) is established by assaying Levels 1 and 2 in triplicate on the applicable instrument system, with a minimum of 6 data points for each level. The mean, standard deviation, and coefficient of variance are then determined.
§ 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.