(56 days)
The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. The CRBM method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (FETINIA) technique which uses a latex particle-carbamazepine conjugate and carbamazepine-specific monoclonal antibody.
Here's an analysis of the provided text, focusing on establishing acceptance criteria and the study proving device-meets-criteria from the perspective of an AI device submission, even though the provided text describes a traditional in-vitro diagnostic device (IVD). I will adapt the questions to fit the IVD context as closely as possible.
Device Name: Carbamazepine FLEX™ Reagent Cartridge
Intended Use: To measure carbamazepine, an anti-convulsant drug, in plasma or serum, for the diagnosis and treatment of carbamazepine overdose and monitoring therapeutic levels.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the traditional IVD submission described, the acceptance criteria are based on method comparison statistics against a legally marketed predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Carbamazepine FLEX™) |
|---|---|---|
| Correlation Coefficient | High correlation (e.g., ≥ 0.95 or 0.97) indicating strong agreement | 0.979 |
| Slope | Close to 1 (e.g., 0.95 - 1.05) indicating proportional agreement | 0.99 |
| Intercept | Close to 0 (e.g., -0.5 - 0.5 µg/mL) indicating constant agreement | 0.06 µg/mL |
| Range of Samples | Comparable to clinical utility range of the drug | 0-18.6 µg/mL |
Note on "Acceptance Criteria (Implied)": The document doesn't explicitly state quantitative acceptance criteria. However, in method comparison studies for IVDs, correlation coefficients close to 1, slopes close to 1, and intercepts close to 0 are generally expected to demonstrate substantial equivalence. These values are derived from typical regulatory expectations for demonstrating equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 82 samples
- Data Provenance: The document does not specify the country of origin of the samples. It also does not explicitly state whether the study was retrospective or prospective, but method comparison studies involving patient samples are typically prospective or use existing, well-characterized archived samples. Given the historical context of IVD development, these would likely be human plasma or serum samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not directly applicable to this type of IVD (analytical performance assessment). For such devices, the "ground truth" for the test set is established by the predicate device's measurement. There are no human experts "establishing ground truth" in the diagnostic sense (like annotating images for an AI). The aca® carbamazepine analytical test pack serves as the reference standard.
4. Adjudication Method for the Test Set
Not applicable. There is no human annotation or interpretation involved that would require an adjudication method. The comparison is between two quantitative analytical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for AI interpretation devices that assist human readers (e.g., radiologists, pathologists). The Carbamazepine FLEX™ Reagent Cartridge is a standalone in-vitro diagnostic device that provides a quantitative measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The study directly compares the quantitative output of the Carbamazepine FLEX™ Reagent Cartridge on the Dimension® system against the aca® CRBAM test pack on the aca® discrete clinical analyzer. There is no human intervention or interpretation that modifies the device's measurement output in this specific performance study.
7. The Type of Ground Truth Used
The type of ground truth used is the measurement obtained from a legally marketed predicate device (aca® carbamazepine analytical test pack). This is a common approach for demonstrating substantial equivalence for new IVDs.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of AI/machine learning. For a traditional IVD like this, there isn't a "training set" in the same sense. The device's performance characteristics (e.g., analytical range, precision, accuracy) are established during its design and development using various experiments, but not a distinct "training set" for an learnable algorithm. If we were to interpret "training" very broadly as the development process that leads to the final device specification, those details are not provided.
9. How the Ground Truth for the Training Set was Established
As noted in point 8, there's no "training set" in the AI sense for this traditional IVD. The development of such a device involves:
- Establishing the chemical/biological principles (FETINIA technique using latex particle-carbamazepine conjugate and carbamazepine-specific monoclonal antibody).
- Optimizing reagents and reaction conditions.
- Calibrating the device using known concentration standards.
These processes intrinsically rely on analytical chemistry principles and traceable reference materials/standards to ensure the device accurately measures carbamazepine, rather than a "ground truth" derived for a training set in a machine learning context.
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.