(49 days)
This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.
This in vitro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system.
The provided document describes the Procainamide Assay for Bayer Immuno 1 System and its comparison to a predicate device, the Syva EMIT® Procainamide Assay.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (Predicate Device Performance) | Reported Device Performance (Immuno 1 Procainamide Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.25 µg/mL | 0.53 µg/mL |
| Precision | Between-Run: | Total: |
| 2.5% @ 2.4 µg/mL | 3.1% @ 2.0 µg/mL | |
| 3.0% @ 5.7 µg/mL | 4.1% @ 7.6 µg/mL | |
| 4.2% @ 9.7 µg/mL | 7.0% @ 9.4 µg/mL | |
| Correlation | (Not explicitly stated as a target, rather the Immuno 1 device's correlation to it is reported) | y = 0.95x + 0.24 (where y = Immuno 1, x = Syva EMIT®) |
| n = 99 | ||
| r = 0.99 | ||
| Syx = 0.27 µg/mL |
Note on Acceptance: The document states that the Immuno 1 Procainamide Assay was found substantially equivalent to the predicate device. This implies that the reported performance metrics of the Immuno 1 assay were deemed acceptable in comparison to the Syva EMIT® Procainamide Assay, even if they are not identical. For instance, the minimum detectable concentration is higher for the Immuno 1, and the precision categories (Total vs. Between-Run) are different, but the overall performance was considered sufficient for substantial equivalence.
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: The correlation study involved n = 99 samples.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" for the test set is typically established by comparative analysis against a validated reference method or another already cleared device (in this case, the predicate Syva EMIT® Procainamide Assay). The study is the comparison against a predicate device, so expert consensus on individual results isn't typically part of this specific type of submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. The study relies on quantitative assay results, not subjective interpretations requiring adjudication.
-
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:
- This information is not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The study described is inherently a standalone performance evaluation of the Immuno 1 Procainamide Assay system (which includes reagents, instrument, and method) against a predicate device. There is no human-in-the-loop component mentioned for the analytical performance of the assay itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence submission is the performance of the legally marketed predicate device (Syva EMIT® Procainamide Assay). The study directly compares the new device's measurements to those obtained from the predicate device to demonstrate similar performance characteristics.
-
The sample size for the training set:
- This information is not provided. IVD assays typically don't have a "training set" in the machine learning sense. The assay is developed and optimized, then validated.
-
How the ground truth for the training set was established:
- This information is not provided and is generally not applicable for this type of IVD device. The methods for establishing the performance characteristics (e.g., linearity, precision, accuracy) during development and optimization would rely on calibrators and controls with known concentrations, potentially traceable to a primary reference standard, rather than a "ground truth" derived from a separate clinical set in the way AI models are trained.
§ 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.