(42 days)
"Rapid Drug Screen" 5-panel with cocaine, marijuana, opiates, amphetamine and methamphetamine is a lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (1000 ne/ml). Benzoyl ecgonine (300 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (300 ng/ml).
"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualatative screening methods that provides only a preliminary result for use in the need for aditional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
"Rapid Drug Screen" provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgement should be applied to any drug of abuse test result, particulary when preliminary positive results are used.
"Rapid Drug Screen" is not intended as a point of care test.
All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between antigens and antibodies.
Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of a visible line in the test area occurs when the test is below the cut-off for the drug.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex.. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present in all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided 510(k) summary for the American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine, structured to answer your questions:
Acceptance Criteria and Device Performance Study for American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine (K993796)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are defined by its ability to qualitatively detect specific drugs of abuse in human urine at or above established cut-off concentrations. The reported device performance is described as successful reproducibility around these cut-off levels.
| Drug | Acceptance Criteria (Cut-off Concentration) | Reported Device Performance (Reproducibility) |
|---|---|---|
| d-Amphetamine | 1000 ng/ml | Confirmed (using control urines above and below cut-off, verified by GC/MS) |
| Benzoyl ecgonine | 300 ng/ml | Confirmed (using control urines above and below cut-off, verified by GC/MS) |
| Cannabinoids | 50 ng/ml | Confirmed (using control urines above and below cut-off, verified by GC/MS) |
| Methamphetamines | 1000 ng/ml | Confirmed (using control urines above and below cut-off, verified by GC/MS) |
| Opiates | 300 ng/ml | Confirmed (using control urines above and below cut-off, verified by GC/MS) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Each sample (control urine above, below, and at cut-off, and negative controls) was tested four times, twice daily, for five days. The total number of individual samples tested is not explicitly stated. However, this indicates a significant number of repetitions per sample to establish reproducibility.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective as it involves the repeated testing of control urines under specified conditions to evaluate reproducibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of human experts to establish the ground truth for the test set in the traditional sense of consensus reading or interpretation.
4. Adjudication Method for the Test Set
No adjudication method involving multiple human readers is described. The ground truth (drug concentration) was established through an objective analytical method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a standalone in-vitro diagnostic test, not an AI assistance tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Performance Characteristics" section describes the evaluation of the device's ability to detect drugs at specified cut-off levels and its reproducibility. This is a study of the algorithm/device only, without human-in-the-loop performance evaluation.
7. Type of Ground Truth Used
The ground truth used for the test set was GC/MS (Gas Chromatography/Mass Spectrometry) verification of drug concentrations. This is a highly accurate and commonly accepted confirmatory analytical method for drug testing, providing an objective, chemical confirmation of the presence and concentration of the target analytes.
8. Sample Size for the Training Set
The document does not explicitly state a training set or its sample size. This type of immunoassay device likely relies on established biochemical principles and manufacturing controls rather than a machine learning model that requires a discrete training dataset in the modern sense. The "training" in this context would be inherent in the device's development and optimization, rather than a separate data-driven training phase as seen in AI/ML applications.
9. How the Ground Truth for the Training Set Was Established
Since a distinct training set (in the AI/ML sense) is not mentioned, the method for establishing its ground truth is also not provided. The development and calibration of such assays typically involve laboratory testing with known concentrations of analytes, verified by methods like GC/MS.
§ 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).