(64 days)
This in viro method is intended to quantitatively measure carbemant drug, in human serum or plasma (heparin) using Syva EMIT 2000 Assay on a Technicon Immuno-1 system. Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.
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Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:
Acceptance Criteria and Device Performance Study
The provided document describes the "Carbamazepine Method for Bayer Technicon Immuno 1 System" and its comparison to a predicate device, the "Syva EMIT® 2000 Carbanazepine Assay."
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but presents performance metrics for both the Immuno 1 Carbamazepine method and the predicate device, implying these are the performance characteristics against which the new device is being evaluated for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied by Predicate Device Performance) | Immuno 1 Carbamazepine (Reported Device Performance) |
|---|---|---|
| Minimum Detectable Conc. | <= 0.5 µg/mL | 0.2 µg/mL |
| Precision (Between-Run) | At 4.0 µg/mL: <= 7.3% CVAt 10.0 µg/mL: <= 5.9% CVAt 16.3 µg/mL: <= 5.6% CV | At 2.8 µg/mL: 3.9% CVAt 9.6 µg/mL: 4.2% CVAt 16.1 µg/mL: 8.7% CV |
| Correlation (vs. Predicate) | A strong positive linear correlation (e.g., r close to 1) with low bias and scatter. | y=1.07x-0.13n = 50r =0.978Syx =0.89 µg/mL |
Note on Precision: While the Immuno 1 demonstrates better precision at lower concentrations (2.8 µg/mL vs. 4.0 µg/mL), its precision at 16.1 µg/mL (8.7%) is worse than the predicate's 5.6% at 16.3 µg/mL. This might be an area for further scrutiny in a full regulatory review, but for the purpose of demonstrating substantial equivalence, direct comparison across the exact same concentration points is sometimes challenging and a "sufficiently similar" performance may be accepted.
Note on Correlation: The regression equation and high correlation coefficient (r = 0.978) indicate a strong linear relationship between the new device and the predicate. The slope of 1.07 suggests a slight positive bias in the Immuno 1 method compared to the predicate, and a y-intercept of -0.13 indicates a small negative offset at very low concentrations. The standard error of the estimate (Syx = 0.89 µg/mL) quantifies the typical deviation of the Immuno 1 results from the regression line.
2. Sample Size and Data Provenance
- Sample size for the test set (correlation study): n = 50.
- Data Provenance: Not explicitly stated. It is not mentioned if the samples were retrospective or prospective, nor their country of origin. Given it's a medical device comparison study, it's highly likely to be human serum or plasma samples.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This study does not involve expert image interpretation or clinical diagnosis by human experts. It's a quantitative measurement device for a specific analyte (carbamazepine) in bodily fluids. The "ground truth" for the test set is established by the results obtained from the predicate device (Syva EMIT® 2000 Carbamazepine Assay).
4. Adjudication method for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for subjective interpretations or classifications, typically in imaging studies. For a quantitative assay comparing against a predicate, the "adjudication" is inherent in the comparison of the numerical results from both assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC study is not relevant for this type of device. This is a laboratory diagnostic instrument, not an AI-powered diagnostic aid for image interpretation.
6. Standalone Performance Study
- Yes (Implicit): The entire document describes the standalone performance of the "Immuno 1 Carbamazepine method." The comparison is between two automated laboratory assays, both operating as standalone systems without human intervention in the measurement process itself, beyond sample loading and results interpretation. The table directly reports the minimum detectable concentration and precision of the Immuno 1 device as a standalone entity. The correlation study evaluates the output of this standalone system against another standalone system.
7. Type of Ground Truth Used
- Reference Device/Predicate Comparison: The "ground truth" for the performance comparison in the correlation study is the results generated by the Syva EMIT® 2000 Carbamazepine Assay, which served as the predicate device. For precision and minimum detectable concentration, the ground truth is derived from repeated measurements or dilutions within the Immuno 1 system itself.
8. Sample Size for the Training Set
- Not Applicable/Not Specified: The document describes a comparison study, not the development or training of an AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning. The Immuno 1 system is a quantitative immunoassay, whose calibration and reagent performance are typically established through internal validation studies by the manufacturer, not through a "training set" like an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI algorithm mentioned, this question is not relevant to the provided text. The "training" for such an immunoassay system involves standard calibration procedures using known concentrations of carbamazepine, as detailed in the method sheets for reagents and calibrators.
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13,1996
SUMMARY OF SAFETY AND EFFECTIVENTAS
Carbamazepine Method for Bayer Technicon Immune 1 System
Listed below is a comparison of the performance between the Immuno 1 Carbamazepine method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® 2000 Carbanazepine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Carbanazepine method sheet and the Syva EMIT® 2000 Carbamazepine Assay insert.
INTENDED USED
This in viro method is intended to quantitatively measure carbemant drug, in human serum or plasma (heparin) using Syva EMIT 2000 Assay on a Technicon Immuno-1 system. Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.
| METHOD | Immuno 1 Carbamazepine | Syva EMIT® 2000(predicate Device) |
|---|---|---|
| Part No. | Reagents T01-3677-51Calibrators T03-3679-01 | Reagents 4F019ULCalibrators 4F109UL |
| Minimum Detectable Conc. | 0.2 µg/mL | 0.5 µg/mL |
| Precision (Between-Run) | 2.8 µg/mL 3.9%9.6 µg/mL 4.2%16.1 µg/mL 8.7% | 4.0 µg/mL 7.3%10.0 µg/mL 5.9%16.3 µg/mL 5.6% |
| Correlation | y=1.07x-0.13 | |
| wherey = Immuno 1 Carbamazepine methodx = Syva EMIT® 2000 Carbamazepine Assay*n = 50r =0.978Syx =0.89 µg/mL |
*This assay was performed on Roche COBAS FARA II® Instrument.
Gabriel J. Murada, Jr.
Manager Regulatory Affairs Baver Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/7/96
Date
§ 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.