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510(k) Data Aggregation
(243 days)
The DRI Methadone Metabolite (100/300) Assay is intended for the qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,5-dighenyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 100 and 300 ng/mL.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. Tests for methadone metabolite cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with test for methadone metabolite and cause false positive results.
The DRI Methadone Metabolite Calibrators are intended for use in calibration of the DRI Methadone Metabolite (100/300) Assay.
The DRI Methadone Metabolite Controls are intended for use in the DRI Methadone Metabolite (100/300) Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.
The DRI Methadone Metabolite (100/300) Assay utilizes liquid ready-to-use reagents. The Antibody/Substrate Reagent (R1) contains mouse monoclonal anti-EDDP antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative. The Conjugate Reagent (R2) contains EDDP-derivative labeled with glucose-6-phosphate Enzyme dehydrogenase (G6PDH) in Tris buffer with sodium azide as a preservative.
The assay uses specific antibodies that can detect EDDP in human urine without cross-reactivity to the parent drug methadone. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) and free drug from the sample for a fixed number of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. This enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Here's a detailed breakdown of the acceptance criteria and study information for the DRI® Methadone Metabolite (100/300) Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (LOQ) | Not explicitly stated as acceptance criteria, but a performance metric. | 14 ng/mL |
| Precision (Qualitative) | All samples spiked below cutoff read negative; all samples spiked above cutoff read positive. | All samples met criteria. |
| Precision (Semi-Qualitative) | Target within-run precision: ≤ 8% CV; Target total-run precision: ≤ 10% CV. | Within-run and total-run precision at all levels of both 100 ng/mL and 300 ng/mL cutoffs met target specifications. |
| Cutoff Characterization (Qualitative) | Negative controls recover < cutoff calibrators; positive controls recover > cutoff calibrators. No overlap between cutoff levels and ± 25% levels with 95% statistical confidence. Precision of 21 replicates < 1% CV. | Controls recovered accurately; negative controls < cutoff calibrators, positive controls > cutoff calibrators. No overlap observed. Precision of 21 replicates was < 1% CV. |
| Cutoff Characterization (Semi-Qualitative) | Recovery < 15% error of nominal values; precision of 21 replicates < 3% CV. | Recovery was < 15% error of nominal values. Precision of 21 replicates was < 3% CV. |
| Linearity (Dilution Recovery) | Recovery within 10% of expected values; correlation coefficient r = 0.9990. | Recovery within 10% of expected values. Correlation coefficient r = 0.9990. |
| Interferences | No significant interference from endogenous and exogenous urine substances at tested concentrations and pH range of 4 to 11. | No significant interference observed from endogenous and exogenous urine substances at the tested concentrations and pH range of 4 to 11. |
| Specificity (Cross-reactivity) | All tested compounds negative (rate below 100 ng/mL cutoff rate; dose recovered < 100 ng/mL). | All compounds tested negative, with rates below the 100 ng/mL cutoff rate and with dose recovered less than 100 ng/mL, indicating no cross-reactivity at tested concentrations. |
| Method Comparison (Qualitative, 100 ng/mL cutoff) | Overall concordance with predicate CEDIA Assay: Not explicitly stated, but high concordance expected for substantial equivalence. Overall concordance with GC/MS: Not explicitly stated, but high concordance expected. | DRI vs. CEDIA: 95% DRI vs. GC/MS: 95% |
| Method Comparison (Qualitative, 300 ng/mL cutoff) | Overall concordance with GC/MS: Not explicitly stated, but high concordance expected. | DRI vs. GC/MS: 99% |
| Method Comparison (Semi-Qualitative, 100 ng/mL cutoff) | Overall concordance with predicate CEDIA Assay: Not explicitly stated. Overall concordance with GC/MS: Not explicitly stated. | DRI vs. CEDIA: 99% DRI vs. GC/MS: 99% |
| Method Comparison (Semi-Qualitative, 300 ng/mL cutoff) | Overall concordance with GC/MS: Not explicitly stated. | DRI vs. GC/MS: 100% |
2. Sample Size and Data Provenance
- Test Set Sample Size: For the "Method Comparison" study, "A total of 100 unaltered patient urine samples" were used.
- Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The samples were "unaltered patient urine samples," suggesting they were naturally occurring specimens. It's not specified if they were retrospective or prospective, but the phrasing implies collection from patients.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth was established by an objective analytical method (GC/MS) rather than expert consensus on subjective interpretations.
- Qualifications of Experts: N/A.
4. Adjudication Method
- Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography / Mass Spectrometry (GC/MS), an objective laboratory method, not human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) assay designed for laboratory analysis, not for interpretation by human readers in a clinical imaging context, for example.
- Effect Size: Not applicable.
6. Standalone Performance Study
- Standalone Study Done? Yes, the "Method Comparison" study evaluated the standalone performance of the DRI Methadone Metabolite Assay by comparing its results directly against the Gas Chromatography / Mass Spectrometry (GC/MS) reference method. Other studies like "Precision," "Cutoff Characterization," "Linearity," "Interferences," and "Specificity" also demonstrate standalone performance characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: Gas Chromatography / Mass Spectrometry (GC/MS) was used as the reference analytical method to establish the ground truth for the method comparison study. This is an objective chemical method considered the "preferred confirmatory method" for drug testing.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not specify a separate "training set" sample size. For an IVD like this, "training" typically refers to the development and optimization of the assay's reagents and parameters rather than a data-driven machine learning model. The provided data focuses on validation and performance evaluation.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable in the context of a machine learning training set. The development of the assay reagents and conditions would be based on chemical principles and optimization to achieve the desired sensitivity and specificity to EDDP in urine matrices. This involves internal studies and experimentation, but not a distinct "training set with ground truth" in the same way as an AI algorithm.
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