(60 days)
The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine). morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:
| COC | Benzoylecgonine | 300 ng/ml |
|---|---|---|
| MOR2000 | Morphine 2000 | 2000 ng/ml |
| MOR300 | Morphine 300 | 300 ng/ml |
| MET1000 | Methamphetamine 1000 | 1000 ng/ml |
| MET500 | Methamphetamine 500 | 500 ng/ml |
| THC | 11-nor- Delta 9 -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| AMP | Amphetamine | 1000 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |
The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
Not Found
This document is a 510(k) premarket notification from the FDA for a diagnostic device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria in the typical format of a clinical trial or algorithm validation study.
However, based on the provided text, we can infer some aspects and extract what information is present, and explicitly state what is missing.
Here's an analysis based on your request, focusing on the available information:
Device Name: QuickTox™ Multiple Drug Dipcard - COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA
Indications For Use: The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
1. A table of acceptance criteria and the reported device performance
The provided document lists "cutoff concentrations" for each drug, which serve as the analytical acceptance criteria for detecting the presence of that drug. The document does not provide specific reported device performance metrics (like sensitivity, specificity, accuracy, positive predictive value, negative predictive value) against a gold standard for these cutoffs in a study. It only states the intended cutoffs.
| Drug / Metabolite | Cutoff Concentration (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| COC (Benzoylecgonine) | 300 ng/ml | Not Reported in document |
| MOR2000 (Morphine 2000) | 2000 ng/ml | Not Reported in document |
| MOR300 (Morphine 300) | 300 ng/ml | Not Reported in document |
| MET1000 (Methamphetamine 1000) | 1000 ng/ml | Not Reported in document |
| MET500 (Methamphetamine 500) | 500 ng/ml | Not Reported in document |
| THC (11-nor-$\Delta^9$-Tetrahydrocannabinol-9-carboxylic acid) | 50 ng/ml | Not Reported in document |
| AMP (Amphetamine) | 1000 ng/ml | Not Reported in document |
| PCP (Phencyclidine) | 25 ng/ml | Not Reported in document |
| BZO (Oxazepam) | 300 ng/ml | Not Reported in document |
| BAR (Secobarbital) | 300 ng/ml | Not Reported in document |
| MTD (Methadone) | 300 ng/ml | Not Reported in document |
| TCA (Nortriptyline) | 1000 ng/ml | Not Reported in 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. The document is a regulatory clearance letter, not a study report.
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 in the document. For drug tests, ground truth is typically established by more definitive analytical methods (e.g., GC/MS), not by expert human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for subjective interpretations (e.g., imaging studies), whereas this device provides visual, qualitative results based on a chemical reaction.
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
An MRMC study is not applicable and was not done as described in the document. This device is an in vitro diagnostic test (a chemical assay), not an AI-assisted diagnostic tool that human readers would interpret. The document refers to "visual, qualitative results for multiple drugs-of-abused in human urine" which implies a direct observation of a color change or line on the dipcard, not interpretation by human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device itself is a standalone test, but it is not an "algorithm" in the typical sense of a software-based AI system. It's a chemical immunoassay. The device provides "visual, qualitative results," meaning a human visually interprets the presence or absence of lines on the dipcard. So, while it's a standalone test, it's not "algorithm-only" and does involve human visual interpretation. The document does not describe a study to evaluate this "standalone" performance against a gold standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for any validation study. For drug screening tests, the ground truth is typically established by a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), which provides highly accurate and quantitative measurements of drug concentrations in urine samples.
8. The sample size for the training set
This information is not provided in the document. As an in vitro diagnostic immunoassay, it doesn't typically have a "training set" in the machine learning sense. Its development involves chemical formulation and optimization.
9. How the ground truth for the training set was established
This information is not provided in the document, as the concept of a "training set" with established ground truth is not explicitly mentioned or applicable in the AI/machine learning context for this type of device based on the provided text. The development of such a device involves analytical validation, likely using spiked samples and clinical samples confirmed by reference methods.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).