(84 days)
The Amedica Drug Screen THC/COC, OPI300, PPX, OXY, BAR/BZO Test is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, oxycodone, secobarbital and oxazepam in human urine at the following cut-off concentration
| THC | 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml |
|---|---|---|
| COC | benzoylecgonine | 300 ng/ml |
| OPI | morphine | 300 ng/ml |
| PPY | propoxyphene | 300 ng/ml |
| OXY | oxycodone | 100 ng/ml |
| BAR | secobarbital | 300 ng/ml |
| BZO | oxazepam | 300 ng/ml |
| This test kit is used to obtain a visual, qualitative result and is intended for use in laboratories and workplaces by trained users. It is not intended for over the counter sale. For in vitro diagnostic use |
Not Found
The provided 510(k) clearance letter and its associated documents (pages 1-3) offer limited information regarding the specific acceptance criteria and detailed study data typically found in a comprehensive medical device submission. This submission appears to be for an in-vitro diagnostic (IVD) drug screen test, which often relies on analytical performance rather than clinical efficacy studies with human readers.
Based on the available text, here's what can be inferred and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document specifies "cut-off concentrations" for each drug, which serve as a critical component of the acceptance criteria for a qualitative drug test. The device's performance would be measured against these cut-offs, typically in terms of accuracy (e.g., sensitivity and specificity) at or around these concentrations. However, the reported device performance values (e.g., sensitivity, specificity, accuracy) are not included in the provided text.
| Drug | Analyte | Cut-off Concentration (Acceptance Criteria) | Reported Device Performance (e.g., Sensitivity, Specificity, Accuracy at cut-off) |
|---|---|---|---|
| THC | 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml | Not provided in the document |
| COC | benzoylecgonine | 300 ng/ml | Not provided in the document |
| OPI | morphine | 300 ng/ml | Not provided in the document |
| PPY | propoxyphene | 300 ng/ml | Not provided in the document |
| OXY | oxycodone | 100 ng/ml | Not provided in the document |
| BAR | secobarbital | 300 ng/ml | Not provided in the document |
| BZO | oxazepam | 300 ng/ml | 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)
This information is not provided in the document. For an IVD, a test set would typically involve a specific number of both negative and positive urine samples (spiked or clinical) tested against the device. The data provenance would detail if the samples were collected retrospectively or prospectively, and their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is generally not applicable in the same way it would be for an imaging AI device. For an IVD like a drug screen, the "ground truth" for the test set is established through a definitive analytical method, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically used when there is disagreement among human readers or when a definitive ground truth is difficult to establish through a single method. For a drug test, the ground truth is established by a confirmatory analytical method, so an adjudication method among experts is not relevant.
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 information is not provided and is not applicable for this type of IVD device. MRMC studies are relevant for imaging or diagnostic devices where human interpretation is a key component and AI provides assistance. This device is a standalone qualitative drug screen. While "trained users" are mentioned, the device itself is not an AI or an assistance tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this device is a standalone qualitative drug screen. The "algorithm" here refers to the biochemical reactions and visual readout mechanism of the test itself, not a digital algorithm in the context of AI. The performance evaluation would have been done to assess the accuracy of the test in detecting the target analytes at or above the specified cut-off concentrations, without human intervention in the result determination beyond visual interpretation of the test line. The document does state: "This assay provides only a preliminary result... To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method." This clearly indicates the device's standalone role in providing an initial, qualitative result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth for an IVD drug screen is typically established by:
- Confirmatory Analytical Methods: Specifically, the document mentions Gas Chromatography/Mass Spectroscopy (GC/MS) as the recommended confirmatory method for obtaining a confirmed analytical result. This is the gold standard for drug detection and quantification in urine.
- Known Concentration Samples: Testing would also involve "spiked" urine samples where known concentrations of the drugs are added, allowing for precise determination of the device's accuracy at different concentrations, especially around the cut-off.
8. The sample size for the training set
This information is not provided. For an IVD of this nature, there isn't a "training set" in the machine learning sense. Instead, the device's design and manufacturing process would be refined based on extensive R&D and internal testing to optimize its performance characteristics (e.g., sensitivity, specificity, stability, reproducibility) before validation studies.
9. How the ground truth for the training set was established
As there isn't a "training set" in the AI sense, this question is not applicable. The underlying chemical principles and immunoassay design are "trained" through biochemical research and optimization, with performance verified against known concentrations of analytes and confirmed by methods like GC/MS during development.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).