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The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy.

Device Description

The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Procainamide reagent kits.

The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of procainamide in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ONLINE TDM Procainamide device:

Acceptance Criteria and Reported Device Performance

The device is evaluated for substantial equivalence to a predicate device (COBAS INTEGRA Procainamide, K951595). The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to the established performance of the predicate device, aiming for comparable or acceptable results. While specific numerical thresholds for "acceptable" are not explicitly stated, the context of substantial equivalence implies that the performance should be within a clinically acceptable range relative to the predicate.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Roche ONLINE TDM N-acetylprocainamide)	Reported Predicate Performance (Roche COBAS FP Procainamide)
Precision	Comparable to predicate
Within-run
- Control 1 Mean	- Comparable	1.7 µg/ml	1.6 µg/ml
- Control 1 SD	- Comparable	0.03 µg/ml	0.05 µg/ml
- Control 1 CV%	- Comparable	1.5%	3.3%
- Control 2 Mean	- Comparable	7.1 µg/ml	6.1 µg/ml
- Control 2 SD	- Comparable	0.07 µg/ml	0.13 µg/ml
- Control 2 CV%	- Comparable	1.0%	2.1%
- Control 3 Mean	- Comparable	11.6 µg/ml	8.5 µg/ml
- Control 3 SD	- Comparable	0.28 µg/ml	0.21 µg/ml
- Control 3 CV%	- Comparable	2.4%	2.5%
Total
- Control 1 Mean	- Comparable	1.7 µg/ml	1.6 µg/ml
- Control 1 SD	- Comparable	0.04 µg/ml	0.05 µg/ml
- Control 1 CV%	- Comparable	2.6%	3.3%
- Control 2 Mean	- Comparable	7.1 µg/ml	6.1 µg/ml
- Control 2 SD	- Comparable	0.27 µg/ml	0.15 µg/ml
- Control 2 CV%	- Comparable	3.8%	2.4%
- Control 3 Mean	- Comparable	11.6 µg/ml	8.5 µg/ml
- Control 3 SD	- Comparable	1.08 µg/ml	0.22 µg/ml
- Control 3 CV%	- Comparable	9.3%	2.6%
Method Comparison	High correlation (r ≥ 0.99)	Linear Regression: y = 1.01x + 0.25, r = 0.998, SD (md 95) = 0.311	Linear Regression: y = 0.944x + 0.20, r = 0.996
		Range = 0.3 - 10.6 µg/ml	Range = 0.13 - 16 µg/ml
Lower Detection Limit	Acceptable results (compared to predicate)	(Specific value not provided, but stated as acceptable)	(Specific value not provided, but stated as acceptable)
Specificity	Acceptable results (compared to predicate)	(Details not provided, but stated as acceptable)	(Details not provided, but stated as acceptable)
Interfering Substances	Acceptable results (compared to predicate)	(Details not provided, but stated as acceptable)	(Details not provided, but stated as acceptable)

Study Details:

Sample sizes used for the test set and the data provenance:
- Precision Studies: The number of runs for the precision studies (within-run and total precision) is not explicitly stated, but the NCCLS guidelines typically involve a specific number of replicates over several days. The data provenance is not specified (e.g., country of origin), but it is a laboratory evaluation in the context of device development. It would be considered prospective for the device under evaluation.
- Method Comparison (ONLINE TDM Procainamide vs. COBAS FP Procainamide): N = 51 serum or plasma samples. Data provenance is not specified. Likely prospective laboratory evaluation.
- Method Comparison (COBAS FP Procainamide vs. COBAS FARA II): N = 156 samples. This is a comparison for the predicate device, not the new device directly, but demonstrates the predicate's performance. Data provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in-vitro diagnostic (IVD) for quantitative measurement of procainamide in human serum or plasma. The "ground truth" here is the actual concentration of procainamide. This is established by validated laboratory reference methods or by the predicate device itself, not typically by expert interpretation in the way a diagnostic imaging device would. Therefore, the concept of "experts" establishing ground truth in the traditional sense for image interpretation or pathology does not directly apply. The predicate device (COBAS INTEGRA Procainamide) served as the reference for comparison in the method comparison study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable (N/A) for this type of IVD device. "Adjudication" refers to resolving disagreements among multiple human readers or experts, which is not relevant for quantitative chemical measurements.
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 (N/A). This is an IVD device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, this study represents a standalone performance evaluation of the ONLINE TDM Procainamide assay. The device itself is an automated clinical chemistry analyzer which quantitatively determines procainamide levels directly from samples. There isn't a human-in-the-loop component in the measurement process, though a human still interprets the results in the clinical context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the new device's performance was established by comparison to a legally marketed predicate device (Roche COBAS INTEGRA Procainamide, K951595), which itself is presumed to have undergone rigorous validation against established analytical methods. For method comparison, the values obtained from the predicate device served as the reference for linearity and correlation. For precision, the "true" mean values for controls are set during their manufacturing and quality control.
The sample size for the training set:
Not applicable (N/A). This device is based on a homogeneous enzyme immunoassay technique, not a machine learning or AI algorithm that requires a "training set." It's a chemical assay.
How the ground truth for the training set was established:
Not applicable (N/A), as there is no "training set" in the context of an enzyme immunoassay.

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