(55 days)
The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.
The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff, The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics.
Here's an analysis of the provided text regarding the Emit® II Opiates 300/2000 Assay, broken down into the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes qualitative and semi-quantitative performance, with different metrics for each.
| Metric (Acceptance Criteria Implied by "Acceptable") | 300 ng/mL Cutoff (Qualitative) | 2000 ng/mL Cutoff (Qualitative) | 300 ng/mL Cutoff (Semi-Quantitative) | 2000 ng/mL Cutoff (Semi-Quantitative) |
|---|---|---|---|---|
| Within-run Precision (CV%) | 0.49 - 0.79% | 0.66 - 0.99% | 2.66 - 4.30% (as concentrations) | 2.49 - 3.33% (as concentrations) |
| Total Precision (CV%) | 0.66 - 0.85% | 0.78 - 1.11% | 3.63 - 5.66% (as concentrations) | 3.74 - 4.65% (as concentrations) |
| Agreement with Predicate Method | 99.4% | 99.4% | Not specified (implied excellent agreement) | Not specified (implied excellent agreement) |
| Agreement with GC/MS Confirmation | 95.3% | 95.3% | Excellent (on basis of concentrations) | Excellent (on basis of concentrations) |
| Spiked Samples (Qualitative) | Correctly distinguished as positive relative to cutoff | Correctly distinguished as positive relative to cutoff | N/A | N/A |
| Spiked Samples (Semi-Quantitative) | N/A | N/A | Quantitated within 20% of mean GC/MS value | Quantitated within 20% of mean GC/MS value |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It mentions "spiked samples" and comparison to a "predicate method" and "GC/MS confirmation," but no specific numbers of samples or origins (e.g., retrospective/prospective, country of origin) are provided for these test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in-vitro diagnostic assay for opiate detection in urine. The ground truth is established through analytical methods (GC/MS confirmation, predicate device comparison) rather than expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established through objective analytical methods. There is no mention of human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretation-based diagnostic devices where human readers are involved. The Emit® II Opiates 300/2000 Assay is an automated in-vitro diagnostic test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance presented is standalone. The Emit® II Opiates 300/2000 Assay is an automated homogeneous enzyme immunoassay. Its performance is measured directly by analyzing urine samples, not through human interpretation or a human-in-the-loop process.
7. The Type of Ground Truth Used
The types of ground truth used are:
- Predicate device comparison: The results were compared to a previously cleared device (Emit® II Opiate Assay, K902577).
- GC/MS confirmation: Gas Chromatography/Mass Spectrometry (GC/MS) is considered the gold standard for drug confirmation in toxicology and thus serves as an objective ground truth for both qualitative and quantitative analysis.
- Spiked samples: Samples with known concentrations of opiates were prepared and tested to assess the assay's ability to correctly identify and quantify them.
8. The Sample Size for the Training Set
The document describes performance studies, but it does not specify a separate "training set" sample size. This type of in-vitro diagnostic device development typically involves analytical validation (precision, accuracy, comparison studies) rather than a machine learning "training set" in the conventional sense. The "performance studies" are essentially the validation data.
9. How the Ground Truth for the Training Set Was Established
As there isn't a "training set" in the machine learning context, this question is not fully applicable. However, the methods used to establish the "ground truth" for evaluating the device's performance (which would inform its development and validation) are the same as those listed in point 7: comparison to a predicate device, GC/MS confirmation, and known concentrations in spiked samples. These methods provide the reference standard against which the assay's accuracy is measured.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).