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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:

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:

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

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepan, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. 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 Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoasay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. 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.

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-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.

It seems you're asking for a structured summary of the acceptance criteria and study results for the "BIO-VENTURE Rapid Multi-Drug Test Easy Cup" and "Split Key Cup" devices, based on the provided FDA 510(k) summary.

Please note that this document describes a qualitative diagnostic test, not an AI-powered device or an imaging system. Therefore, some of your requested points related to AI/MRMC studies, expert readers, and ground truth establishment for complex image analysis are not applicable to this type of device. I will address only the relevant information from the provided text.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for BIO-VENTURE Rapid Multi-Drug Test Easy Cup / Split Key Cup

Device Description:
The BIO-VENTURE Rapid Multi-Drug Test Easy Cup and Split Key Cup are rapid lateral flow immunoassays for the qualitative detection of specific drugs (d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine, and Delta-9-THC-COOH) in human urine. They provide preliminary test results, and a confirmatory chemical method (e.g., GC/MS) is required for confirmed analytical results.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data through precision studies, specificity studies, interference studies, effect of urine specific gravity and pH studies, and comparison to GC/MS studies (clinical samples), as well as a lay-user study.

Acceptance Criteria (Implicit from Study Design and Passed Results):
The acceptance criteria are implicitly defined by the successful demonstration of the device's ability to consistently provide correct qualitative results (positive or negative) within specified concentration ranges relative to the cut-off levels, when compared to a gold standard (GC/MS) and under various testing conditions. For precision, a high concordance rate around the cut-off is expected. For linearity, showing all positive above +25% cut-off and all negative below -25% cut-off. For interference and specificity, showing no false positives or negatives due to common interfering substances or closely related compounds (unless cross-reactivity is expected and quantified). For lay-user studies, a high percentage of correct results by untrained users.

Reported Device Performance (Key Findings from Studies):

Precision Studies (Analytical Performance):

• Sample Concentrations: -100%, -75%, -50%, -25%, Cut off, +25%, +50%, +75%, +100% of cut-off.
• Method: Samples prepared by spiking drug in negative urine, confirmed by GC/MS. Blindly labeled.
• Results (Summary across all drugs and both cup types):
  • Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine, THC:
    • All samples concentrated at or below -25% cut-off consistently showed Negative results (e.g., typically 50-/0+ for all concentrations from -100% to -25%).
    • All samples concentrated at or above +25% cut-off consistently showed Positive results (e.g., typically 50+/0- for all concentrations from +25% to +100%).
    • Samples at the cut-off concentration showed a mix of positive and negative results, which is expected for a qualitative immunoassay at its detection threshold (e.g., for AMP Split Key Cup, Cut off: 22-/28+ to 25-/25+ across batches, meaning 22-25 negative and 25-28 positive out of 50 samples). This demonstrates the device's ability to discriminate around the cut-off.

Linearity (Analytical Performance):

• Results: "Not applicable" in the document, as it's a qualitative test. However, the Cut-off verification study (5.8.1.d) serves a similar purpose.
• Cut-off Verification: A total of 375 samples per device type (Easy Cup, Split Key Cup) across -50%, -25%, Cut-Off, +25%, +50% concentrations.
  • Results: "Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine and Marijuana." This verifies the device's threshold performance.

Stability:

• Result: Stable at 2-30 ℃ for 24 months based on real-time stability.

Interference and Specificity (Analytical Performance):

• Interference: Various physiological/pathological substances (e.g., Naltrexone, Aspirin, Bilirubin, Ethanol) were tested at high concentrations (100 µg/mL or 1% for Ethanol) in drug-free urine and urine spiked at +/- 25% of cut-off.
  • Result: "Compounds that showed no interference at a concentration of 100µg/mL and Ethanol at 1% are summarized in the following tables." The tables list numerous compounds that did not interfere, indicating good specificity against common physiological/pharmaceutical substances.
• Specificity (Cross-Reactivity): Related drug metabolites and other components were tested.
  • Result: Tables provided the lowest concentration causing a positive result and the % cross-reactivity for various substances (e.g., for Amphetamine, D/L-Amphetamine showed 66.7% cross-reactivity at 1500ng/mL; MDMA shows 100,000 ng/mL). This quantifies how other substances react with the test and confirms appropriate specific binding.

Effect of Urine Specific Gravity and Urine pH (Analytical Performance):

• Method: Urine samples with SG 1.002-1.036 or pH 4-9 spiked at +/- 25% of cut-off.
• Result: "Results were all positive for samples at and above +25% Cutoff and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices." This confirms robust performance across a range of physiological urine conditions.

2. Sample Sizes and Data Provenance

• Training Set: The document does not explicitly state a separate "training set" in the context of machine learning, as this is a traditional immunoassay device. The analytical and comparison studies effectively serve as the validation of the device's performance characteristics.
• Test Set (Analytical Performance - Precision):
  • Sample Size: Each drug concentration (9 levels per drug) for 3 lots, tested by 6 operators, with 9 samples per operator per day for 25 days. This results in: 9 concentrations * 3 lots * 6 operators * 9 samples/operator/day * 25 days = 36,450 individual test results for each drug (AMP, COC, OXA, MET, MOP, THC) across all precision studies.
  • Data Provenance: Samples were "prepared by spiking drug in negative samples" and confirmed by GC/MS. This suggests controlled laboratory conditions. The document is for a Chinese manufacturer (Shanghai Venture Bio-Tech Co., Ltd.), so the studies were likely conducted in China or a related territory, but this is not explicitly stated. It's a prospective study as samples were prepared and tested to evaluate device precision.
• Test Set (Clinical Comparison Study):
  • Sample Size:
    • Amphetamine: 87 samples
    • Cocaine: 80 samples
    • Oxazepam: 80 samples
    • Methamphetamine: 81 samples
    • Morphine: 81 samples
    • Marijuana: 82 samples
  • Data Provenance: "unalred clinical samples" tested "in-house." The specific country of origin for these clinical samples is not stated, but given the manufacturer, it's likely China. This is a retrospective study in the sense that existing clinical samples were tested.
• Test Set (Lay-User Study):
  • Sample Size: 20 samples per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off) for each of the 6 drugs and each cup format (Easy Cup, Split Key Cup). Total samples: 7 concentration levels * 20 samples/level = 140 samples per drug per cup type. Multiplying by 6 drugs and 2 cup types gives 1,680 total tests by lay users. Each participant was provided with 1 blind labeled sample and a device.
  • Data Provenance: Samples "prepared at the following concentrations... by spiking drug(s) into drug free-pooled urine specimens." Confirmed by GC/MS. The "lay users" were diverse in background and age, but their geographic location is not specified beyond "three intended user sites" which likely refers to testing locations rather than sample origin. This is a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Ground Truth Method: The primary ground truth for the analytical and clinical comparison studies was Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate and established analytical method used in toxicology for confirmed analytical results of drug concentrations.
• Experts for GC/MS: The document does not specify the number or qualifications of experts operating the GC/MS. GC/MS testing typically requires trained laboratory professionals, but they are not "experts" in the sense of clinical interpretation as in imaging studies. Their expertise lies in analytical chemistry and operating the GC/MS equipment according to established protocols.
• Experts for Device Studies: The clinical comparison studies were performed "in-house with three laboratory assistants for each device." These assistants performed the device testing, but the ground truth was GC/MS. For the lay-user study, the results were compared against GC/MS concentrations.

4. Adjudication Method for the Test Set

• For Lab-based (Precision & Clinical Comparison): The results of the rapid test were compared directly to the quantitative GC/MS results. Discordant results are explicitly listed and discussed. There's no specific "adjudication method" among human readers mentioned, as this is a chemical test, not subjective interpretation.
• For Lay-User Study: The lay users performed the test, and their qualitative results were compared against the GC/MS quantitative concentration data. There was no adjudication mentioned for the lay-user results themselves; rather, their output (positive/negative) was assessed for correctness against the GC/MS reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for imaging devices where human readers interpret medical images, and the AI assists or performs this interpretation. This document describes a qualitative immunoassay (drug test), which does not involve human readers interpreting complex cases in the same way. The studies focused on the analytical performance of the device itself and its accuracy against a chemical gold standard (GC/MS).

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, in essence, the analytical performance and comparison studies represent the "standalone" performance of the device.

• The device itself provides a qualitative result (visible line or no line).
• The precision studies, cut-off verification, interference, and specificity sections evaluate the device's performance in a controlled lab setting, without human interpretation variability being the primary focus (though lab assistants operated the device).
• The comparison study also evaluates the device's direct output (positive/negative) against GC/MS, effectively assessing its standalone accuracy.
• The lay-user study assesses how accurately untrained individuals can use and interpret the device, which is different from "human-in-the-loop" in an AI diagnostic context.

7. The Type of Ground Truth Used

The primary ground truth used for all performance evaluations (precision, linearity/cut-off, clinical comparison, lay-user study) was Gas Chromatography/Mass Spectrometry (GC/MS). For an immunoassay, GC/MS provides a highly accurate and quantitative measurement of the target drug concentration, which serves as the definitive reference for determining whether a sample is truly positive or negative relative to a defined cut-off.

8. The Sample Size for the Training Set

As mentioned, this document does not describe an AI/machine learning device. Therefore, a distinct "training set" in the machine learning sense is not applicable. The development and optimization of the immunoassay itself would have involved numerous experiments and iterations (e.g., antibody selection, membrane optimization), but these are part of the device's manufacturing process, not a data-driven training phase for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of an AI algorithm, this point is not applicable. The device's "ground truth" for development and validation was established by using precisely prepared samples with known drug concentrations, confirmed by GC/MS.

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