(301 days)
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use The detection cutoff concentrations are as follows: THC 11-nor-Δ 9-THC-9-carboxylic acid 50 ng/ mL OPI Morphine 2000 ng/ mL COC Benzoylecgonine 300 ng/ mL MET D-Methamphetamine 500 ng/ mL MDMA 3,4-Methylenedioxymethamphetamine 500 ng/ mL This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Immunoassay for the qualitative detection of methamphetamine and 3,4methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse samples at home or work places. For in vitro Diagnostic Use. The detection cutoff concentrations are as follows: THC 11-nor-Δ⁹-THC-9-carboxylic acid 50 ng/mL OPI Morphine 2000 ng/mL COC Benzoylecgonine 300 ng/mL MET D-Methamphetamine 500 ng/mL MDMA 3,4-methylenedioxymethamphetamine 500 ng/mL This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method.
Status Stik™ THC/OPV/COC/MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine and 3,4-methylenedioxymethamph- etamine.
LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine, and 3,4-methylenedioxymethamphetamine.
Status Stik" MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative detection methamphetamine and MDMA.
Life Sign® Home Drug Test (Ecstasy & MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine and MDMA.
The provided text describes several drug test devices and refers to a "consumer study" for some of them. However, it does not explicitly detail acceptance criteria or the specific study that "proves" the device meets these criteria in the format requested. Instead, it relies on substantial equivalence to predicate devices and, in some cases, mentions overall accuracy from a previous consumer study for a similar device.
Here's an attempt to extract and describe the information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical "acceptance criteria" for accuracy. Instead, for the consumer studies, it refers to an "overall accuracy" percentage from a previous, similar device. The stated cutoff concentrations are part of the intended use, not performance criteria in terms of sensitivity/specificity.
| Analyte | Cutoff Concentration (Intended Use) | Reported Device Performance (Overall Accuracy in Consumer Study for similar predicate device) |
|---|---|---|
| THC | 50 ng/mL 11-nor-Δ⁹-THC-9-carboxylic acid | >95% (LifeSign® Home Drug Test (THC/OPI/COC/MET)) |
| Opiates | 2000 ng/mL Morphine | >95% (LifeSign® Home Drug Test (THC/OPI/COC/MET)) |
| Cocaine | 300 ng/mL Benzoylecgonine | >95% (LifeSign® Home Drug Test (THC/OPI/COC/MET)) |
| Methamphetamine | 500 ng/mL D-Methamphetamine | >95% (LifeSign® Home Drug Test (THC/OPI/COC/MET)) |
| MDMA | 500 ng/mL 3,4-Methylenedioxymethamphetamine | >95% (LifeSign® Home Drug Test (THC/OPI/COC/MET)) |
| Methamphetamine | 500 ng/mL (LifeSign® Home Drug Test (Ecstasy & MET)) | >96% (LifeSign® Home Drug Test (MET)) |
| MDMA | 500 ng/mL (LifeSign® Home Drug Test (Ecstasy & MET)) | >96% (LifeSign® Home Drug Test (MET)) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text only briefly mentions "a consumer study" in the context of predicate devices.
- Sample Size: Not specified for any of the studies mentioned.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The studies are referred to as "consumer studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the given text.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text.
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 is not applicable as the devices are immunoassays, not AI-assisted reading devices. No MRMC study was performed or referenced.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is applicable to the immunoassay devices themselves. The "consumer studies" mentioned imply standalone performance, as the device is designed for home use (without professional human-in-the-loop interpretation beyond reading the result).
7. The Type of Ground Truth Used:
- The text frequently states that these tests "provide only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method." This implies that GC/MS (Gas Chromatography/Mass Spectrometry) is the preferred method for establishing true positivity/negativity, which would be the ground truth for these types of drug screens. However, the studies mentioned (consumer studies) don't explicitly state that GC/MS was used to establish ground truth for the samples in those studies.
8. The Sample Size for the Training Set:
- This information is not provided in the given text. The devices are immunoassays, not machine learning algorithms in the typical sense that would have a "training set."
9. How the Ground Truth for the Training Set was Established:
- This information is not provided in the given text. (See point 8).
Summary of Study Information Provided for Specific Devices:
The document primarily relies on substantial equivalence to previously cleared devices. For the consumer-use devices, it refers to past consumer studies on the predicate devices.
-
LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) (K023837):
- Study: "In a consumer study, LifeSign® Home Drug Test (THC/OPI/COC/MET) showed over 95% overall accuracy."
- Rationale for not performing a new study: "Since LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed."
- Acceptance Criteria (Implied): ">95% overall accuracy" based on the predicate.
- Performance: Stated as "over 95% overall accuracy" for the predicate.
- Ground Truth: Implicitly GC/MS, but not explicitly stated for the consumer study.
-
Life Sign® Home Drug Test (Ecstasy & MET) (K023837):
- Study: "In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy."
- Rationale for not performing a new study: "Since LifeSign® Home Drug Test (Ecstasy & MET) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed."
- Acceptance Criteria (Implied): ">96% overall accuracy" based on the predicate.
- Performance: Stated as "over 96% overall accuracy" for the predicate.
- Ground Truth: Implicitly GC/MS, but not explicitly stated for the consumer study.
For the professional-use devices (Status Stik™, AccuSign®, AccuStik™, AccuStrip™, Status DS™ versions), no consumer study results are mentioned, and equivalence is solely based on their similarity to the predicate devices.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).