(148 days)
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cutoff Level (ng/mL) |
|---|---|---|
| Buprenorphine (BUP) | Buprenorphine | 10 |
| 2-ethylidene-1, 5-dimethyl-3, | ||
| 3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1, 5-dimethyl-3, | |
| 3-diphenylpyrrolidine | 300 | |
| Morphine (MOP300) | Morphine | 300 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use.
The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, or Tricyclic Antidepressants are ingested, at prescribed to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine, or Tricyclic Antidepressants in urine.
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) or an equivalent analytical method is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding , lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Morphine, Propoxyphene, Tri-cyclic Antidepressants and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.
Here's a breakdown of the acceptance criteria and study details for the One Step Single/Multi-drug Test Cup and Dipcard, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for overall device performance (e.g., global sensitivity/specificity targets). Instead, the performance data is presented against the established cutoff concentrations for each drug. The implicitly accepted performance is demonstrated by the agreement between the device's results and the confirmatory methods (GC/MS or HPLC) across different concentration ranges.
The tables below synthesize the performance of the device (both Cup and Dipcard formats, for Single and Multi-drug tests) by showing how results align with concentrations relative to the cutoff. The provided data focuses on the distribution of results across different concentration categories rather than overall accuracy metrics like sensitivity or specificity. However, we can infer performance by observing the agreement rates within each category.
Inferred Acceptance Criteria:
The device is expected to:
- Consistently produce negative results for drug-free samples.
- Consistently produce negative results for samples significantly below the cutoff concentration (less than half the cutoff).
- Demonstrate appropriate discrimination around the cutoff, with increasing positive results as concentrations approach and exceed the cutoff.
- Show agreement with confirmatory methods (GC/MS or HPLC) for samples within and outside the cutoff ranges.
Reported Device Performance (Sample Summary for BUP from 'Single drug Test' and 'Multi-drug Test' for both Cup and Dipcard):
Since the results are identical across all provided tables for BUP, EDDP, MOP, PPX, and TCA for both Single/Multi-drug Test Cup and Dipcard, a representative row is used.
Buprenorphine (BUP) Performance (Representative Example):
- Calibrator: Buprenorphine
- Cutoff Level: 10 ng/mL
| Concentration Category (by GC/MS/HPLC) | Co-Innovation Test Result | Count |
|---|---|---|
| Drug free | + | 0 |
| (n=35) | - | 35 |
| Less than half the cutoff ( 15 ng/mL) | + | 35 |
| (n=35) | - | 0 |
| Total (n=80) | 80 |
Discordant Results (Representative Example for BUP):
- BUP Test: Positive result at 7.8 ng/mL (below 10 ng/mL cutoff). This is a false positive based on the cutoff but within the expected variability around the cutoff.
- TCA Test: Negative result at 1138 ng/mL (above 1000 ng/mL cutoff). This is a false negative.
(Similar tables and discordant results exist for EDDP, MOP, PPX, and TCA, exhibiting comparable patterns.)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 80 clinical urine specimens were used for each drug (BUP, EDDP, MOP, PPX, TCA) for each device type (Single drug Test Cup, Single drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). This means:
- Single drug Test Cup: 5 drugs * 80 specimens = 400 specimens
- Single drug Test Dipcard: 5 drugs * 80 specimens = 400 specimens
- Multi-drug Test Cup: 5 drugs * 80 specimens = 400 specimens
- Multi-drug Test Dipcard: 5 drugs * 80 specimens = 400 specimens
- Total specimens analyzed across all tests and drugs: 1600 individual drug/specimen analyses.
- Data Provenance: The document states "80 clinical urine specimens". It does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by analytical methods, not human experts.
- Number of Experts: Not applicable, as ground truth was not established by human experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
The ground truth was established by definitive analytical methods, not through an adjudication process involving human interpretation of the device results.
- Adjudication Method: Not applicable. The reference method (GC/MS or HPLC) served as the definitive ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described or performed. This device is an in-vitro diagnostic assay for qualitative drug detection in urine, primarily evaluated against gold-standard analytical methods rather than against human readers or human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, the performance data presented is for the device's standalone performance. The "Co-Innovation Result" recorded for each specimen is directly from the device (visual interpretation of the test line on the Cup/Dipcard), without human intervention in interpreting the results. The comparison is made against laboratory-confirmed concentrations, representing the device's intrinsic analytical performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: Analytical confirmation methods:
- Gas Chromatography/Mass Spectrometry (GC/MS)
- High-Performance Liquid Chromatography (HPLC)
8. The Sample Size for the Training Set
The document describes performance studies (accuracy, precision, sensitivity, specificity/cross-reactivity, interference, stability, and home-use consumer study), but it does not specify a separate "training set" or "training data" used for algorithm development, as this device appears to be a lateral flow immunoassay, not a machine learning-based device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an algorithm, this question is not applicable. For quality control during manufacturing and development, external controls and reference materials are typically used, but these are not equivalent to an algorithm's training set in the context of AI/ML.
§ 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).