(52 days)
The DRI® Ecstasy Urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay.
DRI Ecstasy Urine Calibrators are human urine-based and ready to use. They are prepared by spiking negative urine matrix with known quantities of 3,4-methylenedioxymethamphetamine (MDMA). The DRI Ecstasy 500 ng/mL Calibrator is used as the qualitative cutoff reference for distinguishing "positive" from "negative" samples.
The DRI Ecstasy Calibrators available are as follows"
250 ng/mL Calibrator 500 ng/mL Calibrator 750 ng/mL Calibrator 1000 ng/mL Calibrator
The provided text describes the DRI Ecstasy Urine Calibrators and its clearance via a 510(k) submission. It briefly mentions "traditional laboratory studies" for performance characteristics but lacks the detailed information required to fill out many of the requested fields definitively.
Here's an analysis based on the provided text, with N/A for information not present:
1. A table of acceptance criteria and the reported device performance
The document states that "The DRI Ecstasy Urine Calibrators were evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of precision, stability, and accuracy." However, it does not provide specific acceptance criteria or the reported performance values for these characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
| (Specific quantitative thresholds for precision, stability, and accuracy are not provided in the document.) | (Actual numerical results for precision, stability, and accuracy are not provided in the document.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test sets or the provenance of the data. It only generally refers to "traditional laboratory studies."
- Sample Size (Test Set): N/A
- Data Provenance: N/A (implied to be internal laboratory studies, likely U.S.-based given the manufacturer's location, but not explicitly stated).
- Retrospective or Prospective: N/A
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As this device is a calibrator for an immunoassay, the "ground truth" would almost certainly be established by the known concentrations of 3,4-methylenedioxymethamphetamine (MDMA) spiked into the negative urine matrix during the manufacturing process of the calibrators. This does not involve human experts in the same way as, for example, image interpretation.
- Number of Experts: N/A (Ground truth established by manufacturing specifications/spiking)
- Qualifications of Experts: N/A
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as ground truth is based on known concentrations, not expert interpretation requiring adjudication.
- Adjudication Method: N/A
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
This is a calibrator device for an immunoassay, not an AI-powered diagnostic device. Therefore, MRMC studies are not relevant.
- MRMC Study: No
- Effect Size: N/A
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a calibrator device, not an algorithm. Therefore, standalone algorithm performance is not applicable.
- Standalone Study: No
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the calibrators is the known, spiked concentrations of 3,4-methylenedioxymethamphetamine (MDMA) in the negative urine matrix.
- Type of Ground Truth: Known analytical concentrations / manufacturing specifications (spiked concentrations).
8. The sample size for the training set
This is a calibrator device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "development" or "manufacturing" process would involve analytical chemistry and quality control, not machine learning model training.
- Sample Size (Training Set): N/A
9. How the ground truth for the training set was established
Again, as a calibrator, the concept of a "training set" with established ground truth for an algorithm is not applicable. The known concentrations of MDMA for the calibrators are established during their production.
- How Ground Truth for Training Set was Established: N/A (Ground truth is the known spiked concentration of MDMA during manufacturing).
§ 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.