(79 days)
For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology. Carbamazepine in the patient sample competes with an acridinium ester-labeled carbamazepine derivative in the Lite Reagent for a limited amount of monoclonal mouse anti-carbamazepine antibody, which is coupled to paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of carbamazepine present in the patient sample and the amount of relative light units (RLUs) detected by the system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Chiron Diagnostics ACS:180 Carbamazepine Assay:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | Minimum detectable concentration meets therapeutic needs (not explicitly stated numerically, but implied by reporting detection down to 0.2 ug/mL). | Minimum detectable concentration: 0.2 ug/mL (0.8 umol/L) |
| Assay Reportable Range | Ability to measure a relevant therapeutic range (not explicitly stated numerically, but implied by reporting range up to 20 ug/mL). | Measures concentrations up to 20 ug/mL (84.6 umol/L). |
| Method Comparison (Correlation with Predicate) | Strong correlation coefficient to a recognized predicate device (not explicitly stated numerically as a target, but implied by reporting r=0.96). | Correlation coefficient (r) = 0.96 with an alternate fluorescence polarization method. |
| Method Comparison (Regression Equation Slope) | Slope of the regression equation close to 1 (not explicitly stated numerically, but implied by the reported slope of 1.01). | Slope of 1.01 compared to an alternate fluorescence polarization method. |
| Method Comparison (Regression Equation Intercept) | Intercept of the regression equation close to 0 (not explicitly stated numerically, but implied by the reported intercept of 0.71 ug/mL). | Intercept of 0.71 ug/mL compared to an alternate fluorescence polarization method. |
| Precision (Total CV) | Acceptable variability for clinical use (not explicitly stated numerically, but implied by reporting a range of %CV). | Total precision (%CV) ranged from 5.4 to 6.70. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size (Method Comparison): 303 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Given the context of a 510(k) submission from 1996, it's common for such data to be retrospective patient samples, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For this type of assay validation, "ground truth" is established by comparison to results from an established predicate device or a reference method, not by expert interpretation of images or clinical cases.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for this assay is quantitative measurement by a reference/predicate method, not a subjective interpretation requiring adjudication. The method comparison involves comparing numerical results directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This is not an imaging or diagnostic interpretation device typically evaluated with MRMC studies. It's a quantitative immunoassay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, the described performance (sensitivity, reportable range, method comparison, precision) refers to the performance of the assay system itself without direct human intervention in the result determination process for each individual sample once the sample is loaded. The "algorithm" here is the competitive immunoassay chemistry and detection system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the method comparison was established by an alternate fluorescence polarization method, which is a widely accepted and established method for therapeutic drug monitoring. For sensitivity and precision, the ground truth is derived from the assay's own measurements against known concentrations or replicate measurements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated. Immunoassays are "trained" through the development and optimization of their reagents (antibodies, labels, buffers) and calibration curves. The provided documentation focuses on the validation or verification of the final assay's performance rather than a distinct "training set" in the context of machine learning. The calibration process for the assay would implicitly involve a form of "training" or "standardization" with known calibrator concentrations, but the sample size for this specific aspect is not detailed.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: The "ground truth" for calibrating an immunoassay is typically established using reference materials or calibrators with precisely known, gravimetrically or analytically verified concentrations of the analyte (carbamazepine). These calibrators are used to generate a standard curve against which unknown patient samples are measured. The exact process for establishing the ground truth of these calibrators is not detailed in the provided text.
§ 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.