(10 days)
The CHECKCUP™ Multi-Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
| Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|
| AMP | d-Amphetamine | 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC 150 | Benzoylecgonine | 150 |
| COC | Benzoylecgonine | 300 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 |
| MET 500 | d-Methamphetamine | 500 |
| MET | d-Methamphetamine | 1000 |
| MTD | dl-Methadone | 300 |
| OPI 300 | Morphine | 300 |
| OPI | Morphine | 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-A9-THC-9-COOH | 50 |
The CHECKCUP™ Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ is used to obtain a visual, qualitative result and is intended for professional use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
The Ameditech CHECKCUP™ Multi-Drug Test is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in two formats that use identical test strips: Round Cup and Flat Cup. The modified device contains up to seventeen (17) assays that include fourteen (14) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.
Here's an analysis of the provided text regarding the Ameditech CHECKCUP™ Multi-Drug Test, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or accuracy percentages for the CHECKCUP™ Multi-Drug Test. Instead, it relies on demonstrating equivalence to predicate devices. The implicit acceptance criterion is that the modified device performs "as well or better than the predicate device" across various analytical performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Equivalent to predicate devices (K053175, K113046) | "Confirms that the Ameditech CHECKCUP™ has equivalent performance compared with the predicate devices in terms of precision (reproducibility)." |
| Analytical Sensitivity | Equivalent to predicate devices (K053175, K113046) | "Confirms that the Ameditech CHECKCUP™ has equivalent performance compared with the predicate devices in terms of... analytical sensitivity." |
| Analytical Specificity | Equivalent to predicate devices (K053175, K113046) | "Confirms that the Ameditech CHECKCUP™ has equivalent performance compared with the predicate devices in terms of... analytical specificity." |
| Interfering Substances | Equivalent to predicate devices (K053175, K113046) | "Confirms that the Ameditech CHECKCUP™ has equivalent performance compared with the predicate devices in terms of... interfering substances." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that no clinical studies were conducted for this special 510(k) submission (Section E). The performance characteristics were validated in the predicate submissions (K053175 and K113046) and are considered applicable to the modified device.
The study described is a "simplified performance studies" and "analytical performance verification and validation testing." Details on sample sizes for these analytical studies are not provided in the given text.
The data provenance is implied to be from Ameditech, Inc. (the submitter) and likely from internal laboratory testing, given the analytical nature of the studies discussed. There is no mention of country of origin of the data or whether it was retrospective or prospective, though analytical testing is typically prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as no clinical studies were performed. The "ground truth" for the analytical studies would have been established by laboratory methods, not by expert consensus on patient cases.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical studies were performed.
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 applicable. The device is a qualitative lateral flow immunoassay intended for visual reading by a professional, not an AI system. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a lateral flow immunoassay that requires visual interpretation by a human professional. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the context of AI. The performance validated here is inherent to the chemical reactions and visual indicators on the test strip, which are read by a human.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the analytical performance studies (sensitivity, specificity, precision, interfering substances), the ground truth would have been established by reference laboratory methods (e.g., Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are mentioned as preferred confirmation methods for positive results, implying these or similar techniques would be used for analytical validation). The document explicitly states, "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods."
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The device is a chemical immunoassay kit. Therefore, this concept is not applicable in the traditional sense. The development of the test strips and their performance characteristics would have been optimized through iterative laboratory testing and formulation, but not a "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the AI/ML sense is mentioned or implied, this question is not applicable. The underlying principles of an immunoassay rely on antibody-antigen reactions, and the "ground truth" for developing such a device would be based on known concentrations of substances and established analytical 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).