(89 days)
The CEDIA® DAU EDDP Assay is a homogeneous enzy me immunoassay for the in vitro qualitative and semiquantitative determination of EDDP in human urine on automated clinical chemistry analy zers. Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose.
Homogeneous enzyme immunoassay for the determination of EDDP levels in urine.
The provided text describes the Boehringer Mannheim CEDIA® DAU EDDP Assay, a homogeneous enzyme immunoassay for determining EDDP levels in human urine. The information presented is part of a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study report with detailed acceptance criteria and standalone performance.
Here's an analysis of the available information against your requested points:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of a predefined threshold that the device must meet to be considered successful. Instead, it presents performance characteristics (Precision, Qualitative Sensitivity, Rate Separation, Accuracy, and Specificity) and compares them to a predicate device and/or a reference method (HPLC). The implicit "acceptance" is based on demonstrating comparable or improved performance relative to the predicate device or established analytical methods.
Since explicit acceptance criteria are not provided, the table below lists the reported performance data for the CEDIA® DAU EDDP Assay.
| Performance Characteristic | Reported Device Performance (CEDIA® DAU EDDP Assay) |
|---|---|
| Precision | |
| Intra assay 75 ng/ml | N=21, %CV=1.1 |
| Intra assay 100 ng/ml | N=21, %CV=1.0 |
| Intra assay 125 ng/ml | N=21, %CV=1.3 |
| Qualitative Sensitivity | 6.3 ng/mL (3 S.D.) |
| Rate Separation | |
| Negative Calibrator/Low Control to Cutoff (75-100 ng/mL) | 19.4 mAU/min |
| Cutoff to High Calibrator/Control (100-125 ng/mL) | 13.2 mAU/min |
| Accuracy (at 100 ng/mL Cutoff) | |
| Relative Sensitivity vs. DRI EIA | 81.6% |
| Relative Specificity vs. DRI EIA | 95.1% |
| Relative Sensitivity vs. HPLC | 95.4% |
| Relative Specificity vs. HPLC | 98.2% |
| Specificity (Conc. which gives a positive result) | |
| EDDP | 100 ng/mL |
| EMDP (Obs. ng/ml) | 7.4 ng/mL (% Cross-reactivity: 0.004) |
| Methadone (Obs. ng/ml) | 98.6 ng/mL (% Cross-reactivity: 0.016) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Precision: N=21 for each of the three concentration levels (75 ng/ml, 100 ng/ml, 125 ng/ml).
- For Accuracy (Relative Sensitivity/Specificity): The document mentions comparisons to the DRI EIA and HPLC. It does not specify the number of samples (cases) used for these comparisons. It only provides the resulting percentages.
- For Specificity (Cross-reactivity): The specific number of samples for each interfering substance is not explicitly stated, nor is the methodology (e.g., spike-recovery studies).
- Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This specific submission (510(k) summary) does not involve human experts establishing ground truth for image interpretation or clinical diagnosis. The "ground truth" for this in-vitro diagnostic device (immunoassay) is established by:
- Reference Methods: The predicate device (DRI Methadone Metabolite EIA) and an analytical gold standard (HPLC - High-Performance Liquid Chromatography).
- Known Concentrations: Precision studies use samples with known target concentrations (e.g., 75 ng/ml). Specificity studies involve known concentrations of potential interfering substances (e.g., EMDP, Methadone).
Therefore, there were no human "experts" in the sense of radiologists or pathologists establishing ground truth as might be seen in imaging studies.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on analytical reference methods and known chemical concentrations, rather than human review or consensus that would require an adjudication method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The CEDIA® DAU EDDP Assay is an in-vitro diagnostic (IVD) assay that directly measures a substance in urine; it does not involve human readers interpreting results in a way that would be augmented by AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the performance data presented (Precision, Qualitative Sensitivity, Rate Separation, Accuracy, Specificity) for the CEDIA® DAU EDDP Assay are standalone performance of the assay itself. Since it's a chemical immunoassay, it inherently operates without "human-in-the-loop" interpretation in the AI context. The results are quantitative or semi-quantitative measurements directly output by the analytical equipment.
7. Type of Ground Truth Used
The types of ground truth used are:
- Analytical Reference Method (HPLC): For Accuracy (Relative Sensitivity and Specificity), comparison was made against HPLC, which serves as a highly accurate and precise reference method for EDDP quantification.
- Predicate Device (DRI Methadone Metabolite EIA): For Accuracy (Relative Sensitivity and Specificity), comparison was also made against another commercially available and legally marketed device.
- Known Concentrations: For Precision and Specificity, the ground truth is established by preparing samples with known, precise concentrations of the analyte (EDDP) or potential interfering substances (EMDP, Methadone).
8. Sample Size for the Training Set
The document does not provide information about a "training set" for the device. As an immunoassay, this device relies on chemical reactions and optical detection, not a machine learning algorithm that typically requires a training set. If there were method development or optimization studies, those details are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/machine learning algorithm for this immunoassay.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).