(74 days)
Multichem IA Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The Multichem IA Plus control is prepared from human serum to which purified biochemical material (extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is used in liquid form for convenience. Three levels of control are available to allow performance monitoring within the analytical range. Multichem IA Plus Level 1. Level 3 controls are available in tri-level and single level kit configurations. Individual analyte values listed in the package insert are specific for the instrument system utilized.
Here's a summary of the acceptance criteria and study information for the Multichem IA Plus device, based on the provided text:
Acceptance Criteria and Device Performance
The core of the performance evaluation for this device, a quality control (QC) material, revolves around its stability and value assignment accuracy. The established acceptance criteria are related to the stability claims (open vial and shelf-life) and the accuracy of the assigned analyte values.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | Not explicitly stated as a numerical threshold, but implied to be within acceptable analytical variation around a "grand mean." "Pre-determined criteria of 20% around the grand mean and expanded to 30%, if needed, to ensure that 3SD's either side of the mean were within the established range." This is a guideline for establishing the recommended range, not a specific performance metric the device had to meet in a clinical study. | Value assignment ranges were established at the pre-determined criteria of 20% around the grand mean and expanded to 30%, if needed to ensure that 3SD’s either side of the mean were within the established range. The values provided in the instructions for use were derived from replicate analyses and are specific for a particular lot of product. Tests were performed by the control manufacturer and/or by independent laboratories, for various methods and instrument systems. Laboratory means may vary from the values listed during the life of the control. Values are provided only as guidelines, each laboratory should establish its own statistical limits. |
| Open Vial Stability | All analytes stable for 10 days at 2℃ to 8℃ (tightly capped), with specific exceptions: BNP (1 hour), C-Peptide (7 days), Folate (2 days), Homocysteine (7 days), Parathyroid Hormone (4 days), Troponin I (4 days), 25-OH Vitamin D (4 days). | The device met these specified stability criteria for all listed analytes under the described storage conditions. |
| Shelf-Life Stability | Stable for 30 months when stored at -20℃ to -80℃. | A combination of accelerated and real-time testing, utilizing CLSI EP25A, concluded that the Multichem IA Plus controls are predicted to be stable for 30 months when stored at -20℃ to -80℃. Real-time testing is ongoing. |
Study Details
This document describes the regulatory submission for a quality control material and primarily focuses on demonstrating substantial equivalence to a predicate device. The performance characteristics described are related to the analytical performance of the control material itself, rather than a clinical study involving patients or diagnostic accuracy.
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Sample Size used for the test set and the data provenance:
- Value Assignment: The document mentions "replicate analyses" but does not specify the exact number of replicates or the total sample size of control material used for value assignment. It involved testing across "Abbott ARCHITECT i2000 and c8000 Chemistry systems" and by "the control manufacturer and/or by independent laboratories." No specific country of origin is mentioned for this testing, but the manufacturer is based in Ireland. The data is prospective, generated specifically for this submission.
- Stability Testing: No specific sample size (number of control vials or batches) is provided for either open-vial or shelf-life stability studies, only that "internal procedures and two protocols methods" were utilized for open-vial stability and "accelerated and real-time testing" for shelf-life, following CLSI EP25A.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the traditional sense of a diagnostic device. The "ground truth" for a quality control material refers to its assigned analyte values, established through a rigorous process of testing on calibrated laboratory instruments and methods. No human experts are described as establishing a "ground truth" for the test set in the way radiologists or pathologists would for an imaging or pathology study.
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Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of findings to determine a ground truth.
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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 a quality control material, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a laboratory control material, not an algorithm. The performance evaluation is inherently "standalone" in that it assesses the chemical and physical stability and assigned values of the control material itself, independent of real patient samples or diagnostic algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For value assignment: The "ground truth" is established by running the control material on various validated analytical instruments and methods, establishing a "grand mean" for each analyte. This is an analytical 'truth' derived from laboratory measurements, not a clinical ground truth like pathology or expert consensus.
- For stability: The "ground truth" is measured analytical values over time, compared against initial values and established precision requirements.
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The sample size for the training set:
- Not applicable. This is a quality control material and does not involve machine learning algorithms requiring a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this 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.