(258 days)
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine.
Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrators | Cut-off Level |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
The cassette test may be configured as single drug test in any drug analytes listed in the table.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over the counter use.
BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam,
Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrators | Cut-off Level |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
The cassette test may be configured as single drug test in any drug analytes listed in the table.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for prescription use.
The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained
The document describes the performance of the BIO-VENTURE Rapid Amphetamine Test Cassette and similar rapid test cassettes for other drugs (Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana). These are qualitative lateral flow immunoassays designed for both OTC and Rx use.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are implicitly defined by their ability to accurately distinguish between drug concentrations above and below specified cut-off levels. The primary performance metrics presented are precision, cut-off verification, interference, specificity, and comparison with GC/MS results. For the lay-user study, the acceptance criteria are a high percentage of correct results near the cut-off concentrations and ease of use/understanding for lay users.
Table of Acceptance Criteria and Reported Device Performance
| Performance Study | Measured Metric / Acceptance Criterion | Reported Performance |
|---|---|---|
| Precision | Consistent results at specific drug concentrations relative to the cut-off (e.g., all negative below -25% cut-off, all positive above +25% cut-off). | For all assays (AMP, COC, BZO, MET, MOP, THC): |
| -100% to -25% cut-off: 100% negative results across three lots, 6 operators, 25 days (e.g., 50-/0+ for 150 samples per drug per lot category). | ||
| +25% to +100% cut-off: 100% positive results across three lots, 6 operators, 25 days (e.g., 50+/0- for 150 samples per drug per lot category). | ||
| At cut-off: Mixed results as expected (e.g., for AMP, 28-/22+, 26-/24+ across the three lots, indicating some negative/positive calls around the cut-off). | ||
| Cut-off Verification | All results positive at and above +25% Cut-off; all results negative at and below -25% Cut-off. | Achieved for Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine, and Marijuana. Verified against the specified cutoff values. |
| Interference | No interference from common substances at 100 µg/mL (and Ethanol at 1%). | No interference observed from a comprehensive list of tested compounds for all assays. |
| Specificity | Cross-reactivity % and lowest concentration causing a positive result for related substances. | Detailed tables provided for each drug, showing specificity to the target analyte and cross-reactivity with structurally similar compounds. For example, d-Amphetamine showed 100% cross-reactivity at 1000 ng/mL, while d/L-Amphetamine showed 66.7% at 1500 ng/mL. |
| Effect of Urine Specific Gravity & pH | Consistent results across a range of specific gravity (1.002-1.036) and pH (4-9). | Achieved for all assays; results were 100% positive at and above +25% Cut-off and 100% negative at and below -25% Cut-Off. |
| Method Comparison (Clinical Samples) | High concordance with GC/MS results, especially distant from cut-off. Discordant results primarily near the cut-off. | For all drugs, samples well below the cut-off (negative, +50% cut-off) were consistently positive. Discordant results were observed predominantly in samples close to the +/- cut-off value range as expected for rapid qualitative assays, indicating the device's sensitivity is around the stated cut-off. For example, for Amphetamine, 3 operators, 87 samples: |
| Operator 1: 1 Negative at 989 ng/mL (just below 1000 ng/mL cut-off), 1 Negative at 1035 ng/mL (just above cut-off), 1 Negative at 1062 ng/mL. | ||
| Operator 2: 1 Positive at 989 ng/mL, 1 Negative at 1035 ng/mL, 1 Positive at 1062 ng/mL. | ||
| Lay-User Study | High percentage of correct results, especially for clearly negative/positive samples. | |
| Ease of understanding instructions. | For all drugs (AMP, Cocaine, Oxazepam, Methamphetamine, Morphine, Marijuana): | |
| -100% to -50% cut-off: 100% correct negative results. | ||
| +25% to +75% cut-off: 95% to 100% correct positive results. | ||
| At -25% cut-off: 90-95% correct negative results. | ||
| All lay users indicated instructions were easy to follow (Flesch-Kincaid Grade Level 7). |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Precision Study: For each drug assay (AMP, COC, Oxazepam, MET, MOP, THC), there were 6 drug concentrations tested (from -100% to +100% cut-off, skipping -75%, +75%, and -50%, but then showing -75% and +75% in the table). Each concentration likely involved multiple replicates over 25 days across 3 lots and 6 operators.
- The tables show results for 6 concentrations per lot, with 50 results per concentration (e.g., 50-/0+ means 50 negative, 0 positive). With 3 lots and 6 operators, performing 9 samples for 25 days per device, this is a very large number of total tests, difficult to sum precisely from the given table format for all concentrations. However, for a given concentration and lot, it appears 50 tests were performed (e.g., 50-/0+).
- Cut-off Verification: 125 samples tested per drug (equally distributed at -50%, -25%, Cut-Off, +25%, +50% cut-off). Tested using three different lots of each device by three different operators.
- Interference & Effect of Specific Gravity/pH: Not explicitly stated, but implies a similar number of samples at 25% below and 25% above cut-off for each interference/pH/SG factor.
- Comparison Studies (Clinical Samples):
- Amphetamine: 87 samples
- Cocaine: 80 samples
- Oxazepam: 80 samples
- Methamphetamine: 81 samples
- Morphine: 81 samples
- Marijuana: 82 samples
- Lay-User Study: For each drug, 20 samples were tested at each of 7 concentration levels (total 140 samples per drug type).
- Data Provenance: Not explicitly stated regarding country of origin for the clinical samples. The precision samples were prepared by spiking drug in negative samples. The clinical samples were "unaltered clinical samples." The studies were performed "in-house" and at "three intended user sites" (for the lay-user study). The document refers to Shanghai Venture Bio-Tech CO., Ltd. in China, suggesting an origin in China for the test execution, though clinical samples might be from other regions. The studies are prospective in nature, as they involve testing samples under controlled conditions to evaluate device performance.
- Precision Study: For each drug assay (AMP, COC, Oxazepam, MET, MOP, THC), there were 6 drug concentrations tested (from -100% to +100% cut-off, skipping -75%, +75%, and -50%, but then showing -75% and +75% in the table). Each concentration likely involved multiple replicates over 25 days across 3 lots and 6 operators.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Precision Study, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is considered the preferred confirmatory method for drug testing, thus a highly accurate and objective ground truth method. The document states: "Each drug concentration was confirmed by GC/MS."
- For the Method Comparison Studies (Clinical Samples), the ground truth was also established by GC/MS results. The samples were "compared to GC/MS results."
- For the Lay-User Study, the concentrations of the samples were also confirmed by GC/MS.
- The document does not explicitly state the number or qualifications of experts (e.g., radiologists) involved in establishing ground truth, as the ground truth here is analytical (GC/MS) rather than expert consensus on medical images.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method (like 2+1 or 3+1 expert consensus) is mentioned. The ground truth for all performance studies (precision, method comparison, lay-user study) was based on GC/MS, which is an objective chemical method and generally does not require human adjudication in the same way image interpretation might. For the clinical sample comparison, the device results were simply compared against the GC/MS result.
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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:
- This is not applicable to the described device. The device is a rapid diagnostic test (lateral flow immunoassay) for detecting drugs in urine, not an AI-assisted diagnostic tool for human readers interpreting medical images. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is generally applicable because the device itself is a standalone test that produces a visible result (lines on a cassette). Its performance is evaluated independently.
- The "Comparison Studies" with clinical samples and the "Precision Studies" are forms of standalone performance evaluation for the device when operated by trained laboratory personnel.
- The "Lay-user study" also assesses the device's standalone performance, but crucially, it evaluates how well untrained individuals can interpret the device's results.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used for all performance evaluations (precision, clinical comparison, lay-user study samples) was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the laboratory gold standard for confirming drug presence and concentration.
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The sample size for the training set:
- The document describes a medical device (rapid immunoassay cassette), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI/ML model development. The device's "training" corresponds to its chemical and physical design and manufacturing process.
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How the ground truth for the training set was established:
- Not applicable, as there is no AI/ML training set. The ground truth for the testing of these devices was established using GC/MS.
§ 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).