(40 days)
The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin.
The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for these analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an in-vitro diagnostic device consisting of five levels of Lyophilized linearity material containing Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin and additives in human serum. There are five vials labeled A, B, C, D, and E, and contain 5 mL for each level.
Materials of human origin used in the manufacture of this linearity set has been tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
Here's a breakdown of the acceptance criteria and study information for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criterion for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is the demonstration of linearity.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Five-point linear regression value > 0.90 | The study confirms that if the five-point linear regression value is greater than 0.90, and the plots are linear, then the products demonstrate linearity. This indicates that the device's performance met this criterion. |
| Plots are linear | The study confirms that if the five-point linear regression value is greater than 0.90, and the plots are linear, then the products demonstrate linearity. This indicates that the device's performance met this criterion. |
Note: The document explicitly states: "If the five-point linear regression value is greater than 0.90 and if the plots are linear then the products demonstrate linearity." This phrasing indicates these are the conditions for acceptance and that the device met these conditions.
Study Details
This device is an in-vitro diagnostic quality control material, not an AI or imaging device, so many of the requested categories (like MRMC studies, experts for ground truth, adjudication methods, or separate training/test sets for an algorithm) are not applicable in the typical sense. The study focused on demonstrating the linearity of the control material and its stability.
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Sample size used for the test set and data provenance:
- Sample Size: Each analyte was measured 5 times (5 separate vials) at each of the five levels (A through E).
- Data Provenance: Not explicitly stated, but implies internal testing by Aalto Scientific, Ltd. The information available does not indicate country of origin for the data (beyond the company location being Carlsbad, CA) or whether it was retrospective or prospective in the context of human patient data. It is a prospective analytical study performed on the device itself.
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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 as this is a linearity control material. The "ground truth" (target concentration values) was established through repeated measurements on specified instruments (Abbott Axsym and Roche Hitachi 911) using specific reagents. This involves highly trained laboratory personnel but not "experts" in the sense of clinical interpretation for an AI device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The data generation was quantitative measurement. The mean value of five measurements was used to establish the target concentration, which is a statistical method, not an adjudication process.
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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 not an AI or imaging device with human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical quality control material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for each level's concentration was established by mean concentration values from 5 replicate measurements performed on specified laboratory instruments (Abbott Axsym and Roche Hitachi 911) using appropriate reagents. This is effectively an instrument-derived quantitative reference value.
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The sample size for the training set:
- Not applicable as there is no "training set" in the context of an algorithm.
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How the ground truth for the training set was established:
- 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.