(46 days)
The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. propoxyphene and oxycodone in human urine at the following cutoff concentration:
THC: 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic, 50 ng/ml
COC: Benzoylecgonine, 300 ng/ml
OPI: Morphine, 2000 ng/ml
OPI: Morphine, 300 ng/ml
AMP: Amphetamine, 1000 ng/ml
MET: Methamphetamine, 1000 ng/ml
PCP: Phencyclidine, 25 ng/ml
MDMA: 3,4 methylenedioxymethamphetamine, 500 ng/ml
BAR: Secobarbital, 300 ng/ml
BZO: Oxazepam, 300 ng/ml
MTD: Methadone, 300 ng/ml
TCA: Nortriptyline, 1000 ng/ml
PPX: Propoxyphene, 300 ng/ml
OXY: Oxycodone, 300 ng/ml
This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
Not Found
This FDA 510(k) clearance document for the Amedica Drug Screen Test Cup does not contain the detailed study information required to answer many of your questions. This document is a clearance letter, essentially stating that the device is substantially equivalent to legally marketed predicate devices, not a detailed technical report of the studies performed.
Therefore, I can only provide limited information based on the text provided.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a typical table format that would include metrics like sensitivity, specificity, or accuracy. Instead, it defines the "indications for use" by listing the specific drugs detected and their respective cutoff concentrations. The "reported device performance" is not detailed in terms of performance metrics but rather by stating that the device detects these substances at the given cutoffs. An explicit comparison of performance against pre-defined acceptance criteria is not present in this document.
| Drug Name | Cutoff Concentration (ng/ml) | Device Performance (as stated in document) |
|---|---|---|
| 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic (THC) | 50 | Detects THC at 50 ng/ml |
| Benzoylecgonine (COC) | 300 | Detects COC at 300 ng/ml |
| Morphine (OPI) | 2000 | Detects OPI at 2000 ng/ml |
| Morphine (OPI) | 300 | Detects OPI at 300 ng/ml |
| Amphetamine (AMP) | 1000 | Detects AMP at 1000 ng/ml |
| Methamphetamine (MET) | 1000 | Detects MET at 1000 ng/ml |
| Phencyclidine (PCP) | 25 | Detects PCP at 25 ng/ml |
| 3,4 methylenedioxymethamphetamine (MDMA) | 500 | Detects MDMA at 500 ng/ml |
| Secobarbital (BAR) | 300 | Detects BAR at 300 ng/ml |
| Oxazepam (BZO) | 300 | Detects BZO at 300 ng/ml |
| Methadone (MTD) | 300 | Detects MTD at 300 ng/ml |
| Nortriptyline (TCA) | 1000 | Detects TCA at 1000 ng/ml |
| Propoxyphene (PPX) | 300 | Detects PPX at 300 ng/ml |
| Oxycodone (OXY) | 300 | Detects OXY at 300 ng/ml |
Note: The document only states that the device detects these substances at the specified cutoff concentrations. It does not provide metrics like sensitivity or specificity, nor does it explicitly list quantitative acceptance criteria in terms of performance. The "acceptance criteria" here are implied by the cutoff concentrations for detection.
2. Sample size used for the test set and the data provenance
Not specified in the document. This document is a regulatory clearance letter, not a full study report. Information on sample size for testing or data provenance (e.g., country of origin, retrospective/prospective) is not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For a rapid drug screen test, the "ground truth" is typically established by laboratory confirmation methods (e.g., GC/MS), not by human expert consensus or interpretation of images/signals. The document does not describe the methodologies or personnel involved in establishing such ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of complex data (e.g., medical images). For a diagnostic device that provides a qualitative result based on a chemical reaction, such adjudication is not relevant. The document does not mention any adjudication method for its performance evaluation.
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. This device is a rapid in vitro diagnostic test cup, not an AI-powered system or a device that requires human "readers" in the context of image analysis or complex interpretation where an MRMC study would be relevant. There is no mention of AI assistance or human-in-the-loop performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. This is a standalone diagnostic test cup. Its performance is evaluated purely based on its ability to detect the specified substances at the given cutoffs without any human interpretation enhancement (like an algorithm would provide in image analysis). The device provides a "visual, qualitative result" intended for professional use, but this referes to reading the test lines, not complex diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Implicitly, laboratory confirmation methods (e.g., a reference standard like GC/MS). For in vitro diagnostic drug tests, the ground truth for presence/absence of a drug and its concentration is typically established using highly accurate analytical chemistry methods performed in a laboratory, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). The document describes the test cup providing a "preliminary result" and states that "A more specific alternative chemical method is needed to obtain a confirmed result," which reinforces that laboratory-based analytical methods would be the ground truth.
8. The sample size for the training set
Not applicable/Not specified. This is a chemical immunoassay test, not a machine learning or AI-based device that would require a "training set" in the computational sense. The document does not describe any training set data.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not utilize a training set in the AI/machine learning sense.
§ 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).