(72 days)
The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used for the quantitative determination of N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.
The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® NAPA Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle N-acetylprocainamide conjugate and monoclonal N-acetylprocainamide specific antibody. Nacetylprocainamide present in the sample competes with N-acetylprocainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentrtion of N-acetyl procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method:
Summary of Acceptance Criteria and Device Performance:
The document describes a comparative study to demonstrate substantial equivalence to a predicate device, the Dade Behring aca® NAPA analytical test pack (K833378). The primary acceptance criteria appear to be related to the correlation and agreement between the new device and the predicate device.
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance / Acceptance Threshold (Implied) | Device Performance (Dimension® NAPA Flex®) |
|---|---|---|---|
| Intended Use | Same as predicate | in vitro diagnostic use | in vitro diagnostic use |
| Assay Range | Comparable to predicate, potentially broader | 1.0 - 16.0 ug/mL | 0.5 - 30.0 ug/mL |
| Measurement Method | Homogenous immunoassay | EMIT® colorimetric rate 340 nm | PETINIA turbidimetric rate 340 nm and 700nm |
| Correlation with Predicate | Correlation Coefficient | High correlation (implied > 0.95 or similar) | 0.993 |
| Agreement with Predicate | Slope | Close to 1.0 (implied) | 0.96 |
| Agreement with Predicate | Intercept | Close to 0.0 ug/mL (implied) | -0.03 ug/mL |
Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: 73 samples (n=73) were used for the comparative study between the Dimension® NAPA Flex® method and the predicate aca® NAPA method.
- Data Provenance: The document does not specify the country of origin. It indicates the study was a "split-sample comparative performance" evaluation, meaning each sample was tested by both methods. It is a retrospective or prospective study from a practical perspective, as 73 samples obtained from patients (human source) would be retrospectively analyzed by both new and predicate methods.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of immunoassay study typically does not rely on "experts" to establish a ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" or reference is the performance of the predicate device, which is an already legally marketed and accepted method for NAPA quantification. No independent experts were involved in establishing the ground truth for the individual sample concentrations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method was used or needed. The comparison was directly between the quantitative results of the new device and the predicate device.
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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:
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This is a clinical chemistry immunoassay device, not an imaging device that would involve human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance presented for the "Dimension® NAPA Flex® reagent cartridge method" is inherently a standalone performance (algorithm/assay only) without human-in-the-loop interaction beyond the standard operation of the clinical chemistry system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the results obtained from the legally marketed predicate device (Dade Behring aca® NAPA analytical test pack). The study's purpose was to demonstrate substantial equivalence by showing good agreement with this established method.
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The sample size for the training set:
- The document does not explicitly mention a "training set" for an algorithm. For an immunoassay, the development process involves reagent formulation, assay optimization, and calibration. The presented study data (n=73) would be considered part of the validation/test set used for regulatory submission.
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How the ground truth for the training set was established:
- As there's no mention of a traditional "training set" for an algorithm in the context of this immunoassay, the establishment of ground truth for such a set is not applicable. The assay itself is developed and optimized against known standards and controls, not a large "training set" of patient samples for machine learning.
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.