(303 days)
The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant.
This test is intended for over the counter (OTC) consumer use as the first step in a 2-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding the confirmatory testing - the second step in the process-, along with materials for shipping the urine specimen to the laboratory is included with the test. There are no uniformly recognized levels for Benzodiazepine, Oxycodone, Tricyclic Antidepressant, and Barbiturates. The test is not intended to screen individuals who are prescribed these drugs by a physician; the test my yield positive results for individuals taking such drugs, as prescribed.
New Bay HomeCheck Rapid Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000ng/ml of Amphetamine, 1000ng/ml of Methamphetamine, 50ng of THC, 2000ng/ml of Morphine, 300ng of Benzoylecognine, 25ng/ml of Phencyclidine, 300ng/ml of Benzodiazepine, 300ng/ml of Methadone, 100ng/ml of Oxycodone, 1000ng/ml of Tricyclic Antidepressant, and 300ng/ml of Barbiturates. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided 510(k) summary does not include a detailed study or specific acceptance criteria with reported device performance in the format of a table as requested. This document is a pre-market notification that demonstrates substantial equivalence to existing devices (predicate devices) rather than presenting a performance study against predefined acceptance criteria.
However, I can extract information related to the device's technical specifications and intended use, which inherently imply certain performance expectations for this type of immunoassay.
Here's an attempt to structure the available information, noting the limitations of the provided document:
Reported Device Performance and Implied Acceptance Criteria
For rapid immunoassay drug screening devices like the HomeCheck™ Multiple Drug Cup Test, the primary performance measure is its ability to accurately detect the presence or absence of specific drugs at predefined cutoff concentrations, compared to a gold standard (typically GC/MS). While explicit "acceptance criteria" against which a study directly proves performance are not detailed in this summary, the device's stated cutoffs and comparison to GC/MS as the confirmatory method imply accuracy expectations.
Note: The document focuses on demonstrating substantial equivalence to predicate devices and GC/MS, rather than presenting a dedicated clinical performance study with predefined acceptance criteria and a detailed statistical analysis against those criteria. The "Performance" section would typically contain this information, but it is absent here.
| Acceptance Criteria (Implied by Intended Use) | Reported Device Performance (Implied) |
|---|---|
| Qualitative Determination: Detect presence/absence of specified drugs in urine. | The device provides a "simple and rapid analytical screening procedure to detect Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine." |
| Cutoff Concentration: Detect drugs at or above specified cutoff levels. | The device operates with specific cutoff concentrations for each drug: |
- Amphetamine: 1000 ng/ml
- Methamphetamine: 1000 ng/ml
- THC (Marijuana): 50 ng/ml
- Morphine: 2000 ng/ml
- Benzoylecgonine: 300 ng/ml
- Phencyclidine: 25 ng/ml
- Benzodiazepine (Oxazepam): 300 ng/ml
- Methadone: 300 ng/ml
- Oxycodone: 100 ng/ml
- Tricyclic Antidepressant (Nortriptyline HCl): 1000 ng/ml
- Barbiturates (Secobarbital): 300 ng/ml |
| Correlation with Confirmatory Method: Preliminary positive results require confirmation by a more specific alternate chemical method. | "Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." (For TCA, HPLC is preferred). This implies the device provides preliminary results that are then validated by GC/MS/HPLC, but no concordance rates are provided in this document. |
| Assay Time: Completion of test within a specified timeframe. | "5 minutes" assay time. |
Study Information (Based on interpretation of a 510(k) summary)
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Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated. The document refers to "summary" and "information provided," suggesting that underlying data was submitted, but the detailed results and sample sizes for performance evaluation are not included in this public summary.
- Data Provenance: Not specified in this document. Given the submitter is from Tianjin, China, the data could originate from there or other locations. It's also not stated if the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense for this device. The "ground truth" for drug detection in urine immunoassays is typically established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC), which are analytical gold standards, not by human experts interpreting results. The document states: "GC/MS is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant."
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Adjudication method for the test set:
- Not applicable. As noted above, the ground truth is established by analytical methods (GC/MS, HPLC), not by human adjudication of ambiguous cases. The device itself is visually read.
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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:
- No MRMC study was done. This device is a rapid immunoassay test cup for drug screening. It does not involve AI or human readers for diagnostic interpretation in the way a medical imaging AI would. The test is visually read by the user (OTC home use) or a professional, and its result is a preliminary positive or negative, with GC/MS/HPLC for confirmation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. This device is a standalone immunoassay. Its performance is evaluated on its ability to detect specific analytes at given cutoffs. It does not have a "human-in-the-loop" component in terms of interpretive aid. The user simply reads the visual lines. The underlying "algorithm" is the biochemical reaction of the immunoassay itself.
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The type of ground truth used:
- Analytical Gold Standard: Gas Chromatography/Mass Spectrometry (GC/MS) for most drugs, and High-Performance Liquid Chromatography (HPLC) for Tricyclic Antidepressant. This is considered the definitive method for confirming the presence and concentration of drugs/metabolites in urine.
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The sample size for the training set:
- Not applicable/Not provided. Immunoassay devices typically do not have a "training set" in the machine learning sense. Their design and performance are based on chemical specificity and sensitivity studies, often involving spiked samples and clinical samples, but this information is not detailed in the summary.
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How the ground truth for the training set was established:
- Not applicable/Not provided. If "training set" refers to samples used during the development and optimization of the immunoassay, their ground truth would also have been established using analytical methods like GC/MS or HPLC. However, details of such development-phase activities are not part of this 510(k) summary.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).