(141 days)
The AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZQ/MDMA/OXY/MTD/ PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants 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 must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometers (GCMS) 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 used.
Not Found
The provided text describes the AmediCheck Drug Screen Test, an in vitro diagnostic test for the rapid detection of various drugs in human urine. It also includes information regarding its FDA 510(k) clearance (K080872). However, the document does not contain specific information about the acceptance criteria and the study that proves the device meets those criteria in the format requested (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, details of comparative effectiveness studies, or standalone performance data).
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the drugs detected, their cut-off concentrations, and the intended use (professional, not over-the-counter, provides preliminary results, GC/MS for confirmation).
Therefore, I cannot populate most of the requested fields based on the provided text.
Here's what can be extracted and a clear indication of what is not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The document only lists the cutoff concentrations for each drug.
Drug Substance Detected 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 - Reported Device Performance: Not reported in the document (e.g., sensitivity, specificity, accuracy). The FDA letter indicates substantial equivalence, implying that its performance is comparable to its predicates, but specific data is not provided here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document is an FDA clearance letter, not the detailed study report itself.
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)
- Not applicable/Not provided. For drug screens, ground truth is typically established by definitive chemical methods (like GC/MS), not by expert consensus on visual interpretation for the test set itself. The document mentions "professional use" and that "Clinical consideration and professional judgment should be applied," but this refers to the interpretation of results, not the establishment of ground truth for device validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically relevant for studies where multiple human readers interpret data, and their disagreements need resolution. This is less common for a chemical assay like a drug screen where definitive lab methods provide the ground truth for performance validation.
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 an in vitro diagnostic drug screen, not an AI-powered diagnostic imaging tool that requires human reader interpretation that could be augmented by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a rapid diagnostic test providing a visual, qualitative result. While the test itself operates "stand-alone" in terms of producing a result, its performance is evaluated against definitive chemical methods, not typically as an algorithm requiring separate 'standalone' vs. 'human-in-the-loop' analysis in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that Gas chromatography/mass spectrometers (GC/MS) is the preferred confirmatory method for preliminary positive results. This strongly suggests that GC/MS would have been used as the ground truth for validating the device's performance.
8. The sample size for the training set
- Not provided. The document does not refer to a "training set" as this is not an AI/machine learning device. For assay development, there would be development samples, but those details are not in this FDA clearance.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As stated above, this is not an AI/machine learning device with a "training set" in that context.
§ 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).