(28 days)
The HbAlc Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbAlc on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.
HbA1c Controls are manufactured at two levels, Level 1 and Level 2. Each control is prepared from haemolysed human blood with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 2x0.5ml vials and require reconstitution with 0.5ml of distilled water.
The provided document describes the Randox HbA1c Controls Level 1 and 2, which are quality control materials for verifying the performance of laboratory testing procedures of HbA1c on clinical chemistry systems. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets an inherent set of acceptance criteria for its own performance.
Therefore, it is important to note that the acceptance criteria and study described below are derived from the information available in the 510(k) summary, primarily focusing on the value assignment process for the controls and the comparison to the predicate device, rather than a standalone clinical study on the device's diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Reported Device Performance (for Value Assignment) |
|---|---|
| Precision (Coefficient of Variation, CV) | CV should be ≤ 10% for each clinical chemistry analyzer. (Implied met for value assignment) |
| Assigned Target Value Range | +/- 20% range applied to the assigned target value. (Implied met for value assignment) |
| Stability - Opened (2-8°C) | 1 month (if kept capped, original container, free from contamination) |
| Stability - Unopened (2-8°C) | Until expiration date printed on vials |
| Equivalence to Predicate Device | Assessed to be "Substantially Equivalent" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic accuracy or a clinical study for the quality control material itself. The "testing results" mentioned in the conclusion refer to the overall evaluation for substantial equivalence to the predicate device, which includes the value assignment process and stability data.
- Sample Size for Value Assignment: For value assignment, "at least two replicates on each clinical chemistry analyser" are used to calculate a target value. External laboratories contribute NGSP aligned values. The specific number of these external laboratories or the total number of replicates across all analyzers is not stated.
- Data Provenance: The NGSP aligned values are taken from "external laboratories." The country of origin is not specified, nor is whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the traditional sense for a quality control device. The "ground truth" for the controls is the assigned target value.
- Number of Experts: Not applicable. The value assignment method relies on consensus mean from "external laboratories" using NGSP certified methods. These laboratories are assumed to have qualified personnel, but individual experts are not quantified or specified.
- Qualifications of Experts: Not specified. It's implied that the external laboratories use "NGSP certified methods," suggesting that the personnel performing these measurements are qualified to do so, but their specific qualifications (e.g., years of experience, specific certifications) are not detailed.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" for diagnostic performance in the context of human adjudication for this quality control material. The value assignment process uses a consensus mean.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed to assess the performance of a diagnostic device or algorithm in conjunction with human readers. This document describes a quality control material, not a diagnostic device intended to be used by human readers to interpret clinical cases.
6. If a Standalone Study Was Done
Yes, in the sense that the device's performance characteristics (stability and value assignment) were evaluated independently. However, this is not a "standalone" study in the typical AI/diagnostic algorithm context focusing on diagnostic accuracy.
- Standalone Performance: The stability studies (opened and unopened) and the value assignment process describe the performance of the Randox HbA1c Controls themselves.
- Value Assignment: Target values are calculated as the mean of at least two replicates on each clinical chemistry analyzer, and an acceptance criterion for CV (≤ 10%) is applied. A +/-20% range is applied to the assigned target value.
- Stability: Open stability is 1 month at 2-8°C. Unopened stability is until the expiration date at 2-8°C.
7. The Type of Ground Truth Used
The "ground truth" for the HbA1c Controls is their assigned target value. This is established through:
- Consensus Mean: Aggregation of values obtained from "external laboratories" using "NGSP certified methods."
- Traceability: Traceable to IFCC by a master equation and NGSP aligned values.
- Reference Material: Traceable to IFCC by master equation.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material and does not involve AI/machine learning algorithms that require a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.