Search Results

Multichem Alc control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbA1c, as listed in the package insert.

The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. A minimum of two levels of control are available to allow performance monitoring within the clinical range of HbA1c assay method. Multichem A1c control is prepared from human red blood cells with added chemicals and stabilizers. The control is provided in liquid form for convenience.

The provided document describes the Multichem A1c device, which is an assayed quality control material for monitoring the precision of laboratory testing procedures for HbA1c. The study described focuses on the stability and value assignment of this quality control material, rather than the performance of a diagnostic algorithm or device in detecting disease. Therefore, many of the requested categories for a diagnostic device (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, and standalone performance) are not applicable in the traditional sense.

Here's the information that can be extracted and presented based on the context of a quality control device:

1. Acceptance Criteria and Reported Device Performance

Device: Multichem A1c (Assayed) Control

Purpose: Quality Control Material for HbA1c testing.

2. Sample Size Used for the Test Set and Data Provenance

Given this is a quality control material, the "test set" refers to the samples used in the value assignment and stability studies.

• Value Assignment Test Set:
  • Tosoh: n = 45 replicates (over 5 days) for each level.
  • Beckman: n = 23 replicates (over 5 days) for each level.
  • Trinity Biotech: n = 15 replicates (over 5 days) for each level.
  • Data Provenance: Not explicitly stated, but the submission is from Technopath Manufacturing Ltd. in Ireland. The study was conducted in-house. It is a prospective study in the sense that the testing was performed specifically to establish these values.
• Open Vial Stability Test Set: Vials were tested in replicates of 3 at each time-point against a freshly thawed, unopened vial. The number of time points or total number of replicates is not specified but infers a series of measurements over the 30-day period.
• Closed Vial Stability (Accelerated Stress Test) Test Set: 3 separate HbA1c Control lots were tested. Each lot involved testing stressed vials (in duplicate) and fresh (unstressed) samples (in duplicate).
• Closed Vial Stability (Real-time) Test Set: A minimum of 3 lots will be tested at specific time points over the proposed shelf life.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

For a quality control material, "ground truth" is typically established by reference methods or validated laboratory procedures, not by human experts adjudicating clinical cases.

• The "ground truth" (target values) for the control material is assigned through a rigorous value assignment process using calibrated analytical instruments (Tosoh, Beckman, Trinity), performing multiple replicates over several days to establish a mean value. There is no mention of human experts defining the "ground truth" in this context.

4. Adjudication Method for the Test Set

Not applicable. The "test set" values are derived from instrument measurements and statistical analysis (mean, standard deviation), not expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not a diagnostic device involving human readers or interpretation of medical cases. It is a quality control material for instrument performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a biochemical control, not an algorithm. Its "performance" refers to its stability and its ability to consistently provide a known reference value for laboratory instrument calibration/quality checks, not interpretive capabilities.

7. The Type of Ground Truth Used

The "ground truth" for the Multichem A1c control material is established through:

• Instrument-specific mean values: Derived from multiple replicates on calibrated HbA1c analyzers (Tosoh, Beckman, Trinity Biotech). These instruments are themselves calibrated against primary or secondary reference methods for HbA1c measurement.
• Statistical calculation: The target value for the control is the mean value of all replicates generated on the specified instrument, and ranges are set based on imprecision (3 x Standard Deviation) with a minimum applied range of ±10%.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a manufactured biochemical product. The "training data" equivalent might be considered the data used to initially establish the manufacturing process and stability characteristics, but those terms don't fit the AI/ML context.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for its performance as a quality control material is established by the value assignment and stability studies described above.

Ask a specific question about this device