(72 days)
The Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method is used for the quantitative determination of procainamide in serum or plasma. Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring.
The Dade Behring Dimension® Procainamide (PROC) 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® PROC Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle procainamide conjugate and monoclonal procainamide specific antibody. Procainamide present in the sample competes with procainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of 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, focusing on the acceptance criteria and the study details:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: For in vitro diagnostic use, quantitative determination of procainamide in serum or plasma. Measurements for diagnosis and treatment of procainamide overdose and therapeutic drug monitoring. | Intended Use: Matches the predicate device's intended use ("in vitro diagnostic use") and the stated purpose in the "Intended Use" section. Specific use cases (overdose, therapeutic monitoring) are also matched. |
| Assay Range: No specific numerical acceptance criteria stated for the new device as a direct pass/fail, but it performs within a specified range. | Assay Range: 0.5 - 20.0 ug/mL |
| Correlation with Predicate Device (aca® PROC analytical test pack): Demonstrated "good agreement (correlation)". No explicit numerical threshold for "good agreement" is given, but the results are presented. | Correlation Coefficient: 0.997 (indicating very strong positive correlation) |
| Slope (vs. predicate): Expected to be close to 1.0. | Slope: 1.03 |
| Intercept (vs. predicate): Expected to be close to 0.0. | Intercept: -0.02 ug/mL |
Note on Acceptance Criteria: The document describes acceptance criteria primarily through comparison to a legally marketed predicate device (Dade Behring aca® PROC analytical test pack). The acceptance criteria for the new device are implicitly met if its performance characteristics (Intended Use, Assay Range, and comparative performance data) are substantially equivalent to the predicate. The "good agreement (correlation)" is the primary measure for equivalence in this context.
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 89 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense of comparing against an existing method, but the samples themselves could be prospective or retrospective clinical samples. The document refers to "split-sample comparative performance," which implies that 89 patient samples were divided and tested by both methods simultaneously.
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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/Not mentioned. For this type of in vitro diagnostic device (quantitative measurement of a drug level), the "ground truth" is typically the measurement by a comparative method (the predicate device in this case), not an expert consensus on a qualitative diagnosis.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. This is a quantitative assay comparison, not a diagnostic task where expert adjudication of images or clinical findings would be necessary. The comparison is directly between the numerical results of two different analytical methods.
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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. This is not an AI/human reader study; it's a comparison of two in vitro diagnostic (IVD) systems for measuring drug concentration.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The Dimension® Procainamide (PROC) Flex® reagent cartridge method is an automated in vitro diagnostic test. Its performance data (Assay Range, correlation, slope, intercept) were generated by the device itself, without a human "reading" or interpreting the raw data in a way that would be analogous to a radiologist interpreting an image. The human element would be in operating the instrument and processing the samples, but the core measurement is algorithmic.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for evaluating the new device was the measurement obtained from the predicate device, the Dade Behring aca® PROC analytical test pack method. This is a common approach for new IVDs claiming substantial equivalence.
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The sample size for the training set:
- Not specified. The document describes a performance evaluation study (test set), but does not explicitly mention a separate training set. For commercially available immunoassay kits, the "training" (calibration, optimization, etc.) is typically done during the product development and manufacturing phase, often on a larger, internal dataset, not usually detailed in 510(k) summaries for comparison studies.
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How the ground truth for the training set was established:
- Not specified, as a training set is not explicitly mentioned in the context of this 510(k) summary. If one existed, it would likely involve established reference methods or highly characterized samples.
§ 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.