(74 days)
The Methadone or Propoxyphene Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect methadone or propoxyphene in human urine.
The Methadone or Propoxyphene Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect methadone or propoxyphene in human urine.
All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte.
The Negative DAU calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix.
The provided document describes the acceptance criteria and study for Lin-Zhi International, Inc.'s Single Analyte (Methadone or Propoxyphene) Urine Drugs of Abuse Calibrators and Controls. These are not AI/ML devices, but rather laboratory calibrators and controls used for drug testing. Therefore, many of the typical AI/ML study components (like human reader studies, ground truth establishment by experts, training set details, etc.) are not applicable here.
Nevertheless, I can extract the relevant information regarding their performance characteristics and the supporting studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for precision or accuracy in a numerical format that would typically be found in an AI/ML context (e.g., minimum sensitivity, specificity). Instead, it presents the results of performance studies (reproducibility and accuracy) and implicitly suggests that these results demonstrate acceptable performance for the intended use and for substantial equivalence to a predicate device.
The "reported device performance" are the results from the reproducibility and accuracy studies.
Reproducibility (Precision) - Based on %Coefficient of Variation (%CV)
| Calibrator/Control | Expected Concentrate (ng/mL) | Methadone EIA Reported %CV | Propoxyphene EIA Reported %CV |
|---|---|---|---|
| Neg. Cal | 0 | 0.4 | 0.6 |
| Low Cal | 150 | 0.8 | 0.8 |
| Cutoff Cal | 300 | 1.0 | 0.9 |
| Intermediate Cal | 600 | 0.8 | 0.6 |
| High Cal | 1000 | 0.4 | 0.7 |
| Control Level 1 | 225 | 3.4 | 1.3 |
| Control Level 2 | 375 | 3.5 | 2.0 |
Accuracy - Comparison of Expected vs. GC/MS Measured Concentrations (ng/mL)
| Calibrator/Control | Methadone Expected (ng/mL) | Methadone GC/MS (ng/mL) | Propoxyphene Expected (ng/mL) | Propoxyphene GC/MS (ng/mL) |
|---|---|---|---|---|
| Low Cal. | 150 | 157 | 150 | 158 |
| Cutoff Cal. | 300 | 288 | 300 | 307 |
| Intermediate Cal. | 600 | 584 | 600 | 593 |
| High Cal. | 1000 | 963 | 1000 | 973 |
| Level 1 Control | 225 | 214 | 225 | 222 |
| Level 2 Control | 375 | 374 | 375 | 387 |
Stability: The study indicated no significant difference between Calibrators and Controls stored at room temperature for 6 months compared to those stored at 2°C to 8°C. Real-time stability studies were ongoing with an anticipated shelf life of at least 12 months at 2°C to 8°C. Previous evaluations of artificial matrix controls showed >24 months real-time stability.
2. Sample size used for the test set and the data provenance
- Reproducibility Test Set: 12 vials each of Calibrators and Controls for both Methadone and Propoxyphene.
- Accuracy Test Set: The number of samples for GC/MS confirmation is not explicitly stated as a separate "test set" size. The table lists one GC/MS value per calibrator/control level.
- Data Provenance: Not specified, but implied to be from internal lab studies conducted by Lin-Zhi International, Inc. The products contain "human urine-based" matrix, but no geographic origin for the human urine is provided. The study is retrospective in the sense that the data presented is the result of completed tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a chemical calibrator/control, not an imaging or diagnostic AI/ML device that requires human expert interpretation for ground truth. The "ground truth" for calibrator concentrations is established by analytical methods (GC/MS).
4. Adjudication method for the test set
Not applicable. Not an AI/ML device requiring human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. Not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The device itself is the calibrator/control material. The performance characteristics described are how well the calibrators/controls perform in their intended use setting (i.e., in enzyme immunoassays).
7. The type of ground truth used
The "ground truth" for the concentration of the analytes (methadone and propoxyphene) in the calibrators and controls was established using Gas Chromatography/Mass Spectroscopy (GC/MS) technique. This is a highly accurate and widely accepted analytical method for confirming drug concentrations. The reference materials used for spiking were traceable to NIST standards (Methadone) or USP reference standards (Propoxyphene).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses training sets. The calibrators and controls are manufactured to specific concentrations.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is used. The ground truth for the product's declared concentrations is established through manufacturing processes and confirmed using GC/MS (as described in section 7). The calibrators are prepared by spiking known concentrations of drug analyte into a processed, drug-free human urine matrix.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.