Search Results

BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Marijuana (THC): 50 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Cannabinoids (THC): 50 ng/mL
6-Acetylmorphine: 10 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The BIOEASY™ U-Catch MAX Multi-Drug Test Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

Here's a detailed breakdown of the acceptance criteria and study information for the BIOEASY™ U-Catch MAX Multi-Drug Test Cup, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are not explicitly defined as pass/fail thresholds in the provided document, but rather implied by the successful demonstration of performance metrics. The "reported device performance" refers to the results obtained from the various analytical and lay-user studies.

• -100% to -25% Cut-off concentrations: 100% negative results (50-/0+ for each Lot).
• +25% to +100% Cut-off concentrations: 100% positive results (50+/0- for each Lot).
• Cut-off concentration:
  • AMP500: Lot 1 (22-/28+), Lot 2 (26-/24+), Lot 3 (26-/24+)
  • COC150: Lot 1 (28-/22+), Lot 2 (29-/21+), Lot 3 (22-/28+)
  • MET500: Lot 1 (27-/23+), Lot 2 (23-/27+), Lot 3 (25-/25+)
  • EDDP: Lot 1 (24-/26+), Lot 2 (24-/26+), Lot 3 (26-/24+)
  • 6-AM: Lot 1 (26-/24+), Lot 2 (24-/26+), Lot 3 (23-/27+)
    These results consistently demonstrate accurate qualitative detection across the tested range and appropriate performance at the cutoff for all three lots. |
    | | Linearity | Not applicable (qualitative test). | Not applicable. |
    | | Stability and Traceability | Devices should be stable for a reasonable duration at specified conditions. Calibrators should be traceable to commercial reference materials. | Stable at 4-30 ℃ for 24 months based on real-time studies. All drug calibrators traceable to available commercial reference materials. |
    | | Interference | No interference from common physiological/pathological substances or specified compounds at given concentrations. At 25% below cut-off, all results negative. At 25% above cut-off, all results positive. | All tested compounds showed no interference at a concentration of 100 µg/mL. Urine samples spiked with target drugs at 25% below Cut-Off were all negative, and those at 25% above Cut-Off were all positive. |
    | | Specificity | Cross-reactivity with structurally related compounds should be understood and documented, with threshold concentrations causing positive results identified. | Detailed cross-reactivity data provided for each analyte (AMP500, COC150, MET500, EDDP, 6-AM), showing concentrations at which related compounds cause a positive result and their corresponding % cross-reactivity. This demonstrates that the device's specificity profile is characterized and understood. |
    | | Effect of Urine Specific Gravity and pH | Performance should remain consistent across specified ranges of urine specific gravity (1.000 to 1.035) and pH (4 to 9). At 25% below cut-off, all results negative. At 25% above cut-off, all results positive. | Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off for all tested urine specific gravity and pH ranges. Indicates robust performance across these physiological variations. |
    | Comparison Studies | Method Comparison (All Analytes: AMP, COC, MET, EDDP, 6-AM) | High agreement between device results and LC/MS (Liquid Chromatography/Mass Spectrometry) results for clinical samples, especially for samples significantly above and below the cutoff. Limited discordant results near the cutoff are expected for qualitative tests. | For each of the five new analytes, 80 unaltered clinical samples (40 negative, 40 positive based on LC/MS) were tested by 3 laboratory assistants. The tables show very high agreement with LC/MS results outside the near-cutoff range. For instance, for AMP500: 0 positives in "low negative" samples, 0 negatives in "high positive" samples. Discordant results primarily occurred in the "near cutoff" range, which is expected for qualitative tests (e.g., for AMP500, LC/MS results of 473-494 ng/mL (below cutoff) were sometimes positive by the device, and LC/MS results of 520-570 ng/mL (above cutoff) were sometimes negative by the device). These discordant results, being close to the cutoff, are acceptable for a qualitative assay. |
    | Lay-User Study | Ease of Use/Correctness of Results by Lay Users (All 15 Analytes) | High percentage of correct results by lay users demonstrating the device is suitable for OTC use. Instructions should be easily understood. Typically, >90% or >95% accuracy for samples significantly off the cutoff. | 140 lay persons participated.
• Samples significantly below cutoff (-100%, -75%, -50%): 100% correct negative results for all analytes.
• Samples significantly above cutoff (+50%, +75%): 100% correct positive results for all analytes.
• Samples near cutoff (-25%, +25%): Generally 95% correct results across all analytes, with some showing 100%.
  All lay users indicated that the device instructions were easily followed. Flesch-Kincaid analysis showed a reading Grade Level of 7 for the package insert. The high percentage of correct results by lay users demonstrates the device's suitability for OTC use. |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Precision Studies: For each of the 5 new analytes (AMP, COC, MET, EDDP, 6-AM), 9 concentrations were tested across 3 lots. Each concentration was tested two runs per day for 25 days. Total samples for precision: 5 analytes * 9 concentrations * 3 lots * 25 days * 2 runs/day = 6,750 individual tests.
  • Method Comparison Studies: For each of the 5 new analytes, 80 unaltered clinical samples (40 negative and 40 positive) were tested. Total samples for method comparison: 5 analytes * 80 samples = 400 clinical samples.
  • Lay-User Study: 140 lay persons. Each participant (lay person) received one blind-labeled sample and a device. For each of the 15 analytes, there were 7 concentration levels tested, with 20 samples per level. Total unique tests performed by lay users: 15 analytes * 7 concentration levels * 20 samples/level * 1 device/sample = 2,100 tests.
• Data Provenance:
  • Precision Studies: Samples were prepared by spiking drug in negative urine samples. "Each drug concentration was confirmed by LC/MS." This suggests prepared samples, not necessarily clinical samples.
  • Method Comparison Studies: Unaltered clinical samples. The country of origin is not specified but is likely from the United States given the FDA submission context. The study is retrospective as these were "unaltered clinical samples" which typically implies pre-collected samples.
  • Lay-User Study: Urine samples were prepared at various concentrations by spiking drugs into drug-free pooled urine specimens. The concentrations were confirmed by LC/MS. This indicates a controlled, prospective study design using artificially prepared (but LC/MS confirmed) samples. Country of origin not explicitly stated, but performed at "three intended user sites" which likely corresponds to a US setting for OTC validation.

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

• Precision Studies: Ground truth (drug concentration) was established by LC/MS. The document states that "Each drug concentration was confirmed by LC/MS," indicating a highly accurate analytical method. This method does not typically involve human experts for interpretation in the same way clinical imaging or pathology might.
• Method Comparison Studies: Ground truth was established by LC/MS results. The study directly compared the device results to LC/MS results. Again, this is an analytical method, not requiring expert human interpretation from a medical perspective (like radiologists).
• Lay-User Study: Ground truth (drug concentration) was established by LC/MS. "The concentrations of the samples were confirmed by LC/MS." No medical experts were involved in establishing the ground truth for these samples. The "experts" in this context were the personnel operating the LC/MS equipment, who would be trained lab technicians or chemists.

4. Adjudication Method for the Test Set

• Precision Studies: No explicit adjudication method described. The results are quantitative (expressed as number of positive/negative readings) and directly compared to the known LC/MS concentration of the spiked samples.
• Method Comparison Studies: No explicit adjudication method described beyond direct comparison to LC/MS results. Discordant results are individually listed but not subject to a separate adjudication process beyond the LC/MS reference.
• Lay-User Study: No explicit adjudication method described. Lay person results were directly compared to the known (LC/MS confirmed) concentration of the samples. The primary focus for the lay-user study appears to be the percentage of correct results at various concentrations, not reconciliation of disagreements between readers or methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done in the conventional sense of human readers interpreting medical images or data with and without AI assistance.
• The "Method Comparison Studies" involved three laboratory assistants as "viewers" interpreting the test cups. This could be considered a multi-reader study, but it was comparing the device's performance to LC/MS as a reference, not comparing human readers' performance with and without AI.
• The "Lay-user study" involved 140 lay persons interpreting the device. This is a multi-reader study for ease of use and interpretation, but not focused on clinical comparative effectiveness against experts or AI assistance.
• Therefore, no effect size for human readers improving with AI vs without AI assistance can be reported from this document as the device is a drug test cup, not an AI diagnostic tool and the studies were not designed for this type of comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The device described is a "competitive binding, lateral flow immunochromatographic assay" in the form of a "Multi-Drug Test Cup." This is a physical or chemical diagnostic test, not a software algorithm or AI.
• Therefore, the concept of a "standalone algorithm" does not apply here. The device itself is the standalone test that produces a visual result (a line or absence of a line). Its performance is its standalone performance. The "human-in-the-loop" here refers to the human interpreting the visual result, which is evaluated in the lay-user study.

7. The Type of Ground Truth Used

• The primary ground truth used across all analytical performance studies (Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH) and the Method Comparison Studies was LC/MS (Liquid Chromatography/Mass Spectrometry).
• For the Lay-User Study, the ground truth for spiked samples was also established by LC/MS.

8. The Sample Size for the Training Set

• No explicit training set is mentioned in the context of this device. This is because the BIOEASY™ U-Catch MAX Multi-Drug Test Cup is a lateral flow immunoassay, which is a chemical/biological test, not a machine learning or AI model that requires a "training set" in the computational sense. The device is developed and validated through laboratory experimentation and calibration rather than a data-driven training process.

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

• As there is no "training set" in the context of a machine learning or AI model, this question is not applicable. The performance characteristics were established through standard laboratory testing procedures using known concentrations of analytes, confirmed by LC/MS.

Ask a specific question about this device