(63 days)
The On-Call™ Multi-Drug Home Test Cup is a screening test for the rapid detection of drugs in urine at a designated cut-off concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 500 ng/mL for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. The test is intended for over-the-counter (OTC) consumer use.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
The On-Call™ Multi-Drug Home Test Cup is a rapid lateral flow immunoassay for the qualitative detection of drugs in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 500 ng/mL for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test is used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for the over-the-counter lay person use.
The On-Call™ Multi-Drug Home Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of drugs, and their metabolites in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 500 ng/ml for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test can be performed without the use of an instrument.
A drug-positive urine specimen will not generate colored-lines in the designated test region, while A urine specimen or a urine specimen containing Marijuana, Cocaine, Amphetamine, a megative anne specimen or a anno epididine at the concentration below the cutoff level will generate colored-lines in the test region. To serve as a procedural control, a colored-line whit generate control miss in antol region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided text does not contain acceptance criteria for the device, nor does it detail a study performed to prove the device meets specific acceptance criteria in the way described in the request.
Instead, the document is a 510(k) summary for a drug test cup. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (ACON Spectrum Multi-Drug Multi-Line Drug Screen Test, K031759) and establishing the device's technical characteristics and intended use.
Here's an breakdown of why the requested information cannot be extracted from the provided text:
- No explicit acceptance criteria table: The document does not list specific sensitivity, specificity, accuracy, or other performance metrics as acceptance criteria.
- No detailed study report: The document states that the new device (On-Call™ Multi-Drug Home Test Cup) is "identical to the ACON Key Cup (K031759) that is legally marketed for professional use." It then argues that "there is no issue regarding the safety or effectiveness of the product to perform its intended function" because of this similarity and the device's simple operation. This is a declaration of equivalence rather than a report of a new study proving performance against defined criteria.
- Focus on Substantial Equivalence: The FDA's letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed performance study.
Therefore, many parts of the requested table and information points cannot be filled based on the provided document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
As stated, the document does not contain explicit acceptance criteria or a dedicated performance study for the On-Call™ Multi-Drug Home Test Cup. The performance is implied to be equivalent to the predicate device due to identicality.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Marijuana (THC) | Not specified | Qualitatively detects THC at a cutoff of 50 ng/mL. Implied to be equivalent to predicate K031759. |
| Cocaine (COC) | Not specified | Qualitatively detects COC at a cutoff of 300 ng/mL. Implied to be equivalent to predicate K031759. |
| Amphetamine (AMP) | Not specified | Qualitatively detects AMP at a cutoff of 1,000 ng/mL. Implied to be equivalent to predicate K031759. |
| Methamphetamine (mAMP) | Not specified | Qualitatively detects mAMP at a cutoff of 1,000 ng/mL. Implied to be equivalent to predicate K031759. |
| Ecstasy (MDMA) | Not specified | Qualitatively detects MDMA at a cutoff of 500 ng/mL. Implied to be equivalent to predicate K031759. |
| Opiates (OPI) | Not specified | Qualitatively detects OPI at a cutoff of 2,000 ng/mL. Implied to be equivalent to predicate K031759. |
| Phencyclidine (PCP) | Not specified | Qualitatively detects PCP at a cutoff of 25 ng/mL. Implied to be equivalent to predicate K031759. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document relies on the equivalence to a previously cleared device rather than presenting new test set data.
- Data provenance: Not specified.
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 as no new test set and associated ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no new test set is described.
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 immunoassay for qualitative detection of drugs, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a standalone test in that it provides a result without an instrument or human interpretation for its primary detection, though confirmation by GC/MS is required for positive results. However, no "standalone performance study" in the context of an algorithm is presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the predicate device (K031759) and by implication for this equivalent device, the principle of ground truth for drug testing is typically established by definitive confirmatory methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis."
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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).