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The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.

EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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 tests are intended for over-the-counter and for prescription use.

The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.

EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS 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 tests are intended for over-the-counter and for prescription use.

EGENS Urine Test Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is 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 provided document describes the performance characteristics of the EGENS Urine Test Cup Morphine - Methamphetamine and EGENS Urine Test DipCard Morphine - Methamphetamine devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" but rather presents performance characteristics from various studies. For the purpose of this response, I infer the reported performance to be the intended criteria and thus list the results.

Morphine (MOP) and Methamphetamine (MET) Detection
Cut-off for Morphine: 300 ng/mL
Cut-off for Methamphetamine: 1000 ng/mL

2. Sample Size and Data Provenance

• Precision Studies: For each concentration level (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), 50 tests were performed per lot. With 3 lots and 9 concentrations, this is 50 * 3 * 9 = 1350 tests per drug for each device format (Cup/DipCard).
  • Data Provenance: Not explicitly stated, but the studies were conducted in-house. This typically implies controlled lab conditions rather than real-world patient samples, but the samples themselves are referenced as "samples with concentrations."
• Cut-off Studies: A total of 125 morphine samples and 125 methamphetamine samples were used, equally distributed across 5 concentration levels (-50%, -25%, cut-off, +25%, +50%).
  • Data Provenance: Not explicitly stated, but implied to be controlled, spiked samples.
• Interference/Specificity Studies: Samples were prepared by adding potential interfering substances or drug metabolites to urine containing target drugs. The quantity of samples is not explicitly given but implied to be sufficient for testing (e.g., "These samples were tested using three batches...").
  • Data Provenance: Not explicitly stated, likely controlled lab conditions.
• Effect of Specific Gravity and Urine pH: 12 urine samples covering normal, high, and low specific gravity ranges, and urine pH adjusted to 4.00-9.00 in 1 pH unit increments. These were spiked samples.
  • Data Provenance: Not explicitly stated, likely controlled lab conditions.
• Laboratory Comparison Studies: 80 "unaltered clinical samples" (40 negative and 40 positive) for each drug (Morphine and Methamphetamine) per device format (DipCard, Cup). This means 80 * 2 (drugs) * 2 (formats) = 320 samples in total for this part of the study.
  • Data Provenance: "Clinical samples" are explicitly stated, implying these are from actual patients rather than purely synthetic or spiked lab samples. The country of origin is not specified but the study was performed "in-house."
• Lay-User Study: 560 lay persons. The study used 80 "drug-free samples", 240 "morphine samples", and 240 "methamphetamine samples". Within these, the document describes 20 samples per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off) per drug.
  • Data Provenance: Urine samples were "spiked drugs into drug free-pooled urine specimens." So, these were controlled, spiked samples, not unalterted clinical samples.

3. Number of Experts and their Qualifications for Ground Truth

• Laboratory Comparison Studies: "Three laboratory assistants" were involved in running the tests. Their qualifications are not specified beyond being "laboratory assistants."
• Precision, Cut-off, Interference, Specific Gravity/pH Studies: "Three operators" repeatedly tested the samples. Their qualifications are not specified.
• Lay-User Study: The "lay persons" were the "users" in this study, not "experts" establishing ground truth. There were 560 lay users. Their qualifications were described as having "diverse educational and professional backgrounds and ranged in age from 21 to >50 years."

4. Adjudication Method for the Test Set

• Laboratory Comparison Studies: The collected results from the three viewers/operators were directly compared to the GC/MS results. There is no explicit mention of an adjudication process (e.g., 2+1, 3+1) among the viewers to establish a consensual device output. Each viewer's result was compared to GC/MS independently.
• Other Studies (Precision, Cut-off, Interference, etc.): The results were aggregated from multiple operators/lots, but the tables present aggregated counts (e.g., 50-/0+, 33+/17-), not individual operator adjudication.
• Lay-User Study: Each participant was given one blind-labeled sample and a device. Their individual results were recorded and compared to the GC/MS ground truth. No adjudication between lay users is mentioned.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no mention of a formal MRMC comparative effectiveness study or analysis of how much human readers improve with AI vs. without AI assistance. The study involves human readers (operators/lay users) interpreting the results of the device, but it does not compare their performance with and without an AI or advanced assistance system. It is a standalone device performance comparison against GC/MS.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop)

The devices described (EGENS Urine Test Cup and DipCard) are rapid, qualitative immunoassay tests that rely on visual interpretation of results (presence or absence of colored lines). They are not "algorithms" in the computational sense, and there is no "algorithm only" or "standalone" performance without human-in-the-loop, as human interpretation of the visual result is integral to the device's function. The "laboratory comparison study" and "lay-user study" assess the device's performance when interpreted by humans.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH): The ground truth was established by precise spiking of known concentrations of the target drug or interfering substances into drug-free urine.
• Laboratory Comparison Studies: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the preferred confirmatory method and thus, the primary ground truth reference.
• Lay-User Study: GC/MS was used to confirm the concentrations of the spiked samples, serving as the ground truth.

8. Sample Size for the Training Set

The document describes premarket notification (510(k)) studies to demonstrate substantial equivalence, not the development of a predictive model or algorithm that would typically involve a "training set." Therefore, no training set size is mentioned or applicable in the context of these device types and studies. The tests are immunoassays, not machine learning models.

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

As stated above, this document does not describe the development of a device requiring a "training set" for a machine learning algorithm. The "training set" concept is not applicable here.

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CR3 Keyless Split Sample Cup Morphine-Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. The test is 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 test is intended for over-the-counter and for prescription use.

The CR3 Keyless Split Sample Cup Morphine-Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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 CR3 Keyless Split Sample Cup Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is 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 acceptance criteria and the study proving the device meets these criteria are detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the overall device performance in a consolidated table. However, implied acceptance criteria can be derived from the precision and lay-user study results, particularly around the cutoff concentrations. For the purpose of this response, I will synthesize the observed performance from the precision and lay-user studies as the "reported device performance" against common expectations for such devices.

Implied Acceptance Criteria and Reported Device Performance for Morphine (MOP) and Methamphetamine (MET) Detection:

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

• Precision Study:

  • For each concentration level (-100% to +100% of cut-off), 50 tests were performed per lot. With 9 concentration levels and 3 lots, this implies a total of 450 tests per drug (Morphine and Methamphetamine).
  • Data Provenance: Not explicitly stated, but the study was "carried out" by the manufacturer. It is implied to be a prospective analytical study using spiked samples designed to test device precision. The samples were "masked and randomized."

• Cut-off Study:

  • A total of 125 morphine samples and 125 methamphetamine samples were used. These were distributed at -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs.
  • Data Provenance: Not explicitly stated, but "samples were tested using three different lots by three different operators." This is an analytical study.

• Interference Study:

  • Not specified, but likely in-house analytical testing using spiked urine samples.

• Specificity Study:

  • Not specified, but likely in-house analytical testing using spiked urine samples.

• Effect of Specific Gravity and Urine pH Study:

  • 12 urine samples (normal, high, low specific gravity) were spiked for each drug.
  • pH study: Aliquots of negative urine pool adjusted to pH 4.00-9.00 (6 increments) were spiked for each drug.
  • Data Provenance: In-house analytical testing.

• Comparison Studies (Algorithm Only / Standalone Study Implicit):

  • 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug (Morphine and Methamphetamine).
  • Data Provenance: "In-house with three laboratory assistants." The samples were "unaltered clinical samples," suggesting real human urine samples, and were "masked and randomized." The country of origin is not specified but implicitly where the manufacturing facility is located (Guangzhou, P.R. China) or where the testing was conducted. This study appears to be a standalone performance evaluation against a gold standard method.

• Lay-User Study:

  • 260 lay persons participated.
  • Sample distribution: 20 drug-free samples, 120 morphine samples, and 120 methamphetamine samples.
  • Sample concentrations: -100%, +/-75%, +/-50%, +/-25% of the cut-off.
  • Data Provenance: Clinical study performed "at three intended user sites" using spiked drug-free pooled urine specimens. The samples were "blind-labeled and randomized."

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

• Precision, Cut-off, Interference, Specificity, Specific Gravity/pH Studies: "Three operators" conducted these tests, but their qualifications are not specified beyond being "operators." The ground truth for these analytical studies was based on the precisely known concentrations of spiked drug analytes.

• Comparison Studies (Clinical Samples):

  • Ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing and considered a gold standard. No human experts are explicitly mentioned for establishing ground truth from GC/MS, as it is an objective analytical method.
  • Three "laboratory assistants" were the "operators" who read the device results. Their qualifications are not specified.

• Lay-User Study:

  • The ground truth for the spiked concentrations was "confirmed by GC/MS." No human experts are explicitly mentioned for establishing ground truth from GC/MS.

4. Adjudication Method for the Test Set

The document does not describe a formal "adjudication method" involving multiple readers for reconciling discrepancies in the test results.

• Precision, Cut-off, Interference, Specificity, Specific Gravity/pH Studies: The results are presented as counts (e.g., 50-/0+), implying individual test outcomes were recorded, not adjudicated.
• Comparison Studies: Three "Viewers" (A, B, C) individually read the results of the 80 clinical samples for each drug. Their individual results are reported, including discordant cases, but there's no mention of a consensus or adjudication process among them. Each viewer's performance is listed separately.
• Lay-User Study: Each participant (lay person) received one device and one blind-labeled sample. Their individual interpretation was recorded and compared to the GC/MS confirmed concentration. No adjudication among lay users is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not explicitly performed or reported.

The "Comparison Studies" involved three "laboratory assistants" (referred to as Viewers A, B, C) interpreting device results. This is a multi-reader study, and the cases were clinical samples. However, there's no "AI assistance" component mentioned to evaluate an improvement effect size over unassisted human reading. The device itself is an immunochromatographic rapid test, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was implicitly done.

The "Comparison Studies" section evaluates the performance of the CR3 Keyless Split Sample Cup Morphine - Methamphetamine device alone against GC/MS results for "unaltered clinical samples." The device itself is the "algorithm only" in this context, as it is a rapid diagnostic test providing a qualitative result (positive/negative line on the strip). The three laboratory assistants are merely "reading" the output of the device. The data provided in the tables for "Viewer A, B, C" in the Comparison Studies section actually reflect the performance of the device as interpreted by different individuals.

7. Type of Ground Truth Used

• For all analytical studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH): The ground truth was based on known spiked concentrations of the target analytes in urine.
• For Comparison Studies (Clinical Samples) and Lay-User Study: The ground truth was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is considered a definitive analytical method for confirming drug presence and concentration.

8. Sample Size for the Training Set

The document describes premarket performance characteristics and refers to a "device" that is an immunochromatographic assay. This type of device does not typically involve a "training set" in the context of machine learning or AI models. Its performance is based on the chemical and biological properties of its reagents and manufacturing process, which are developed and validated through iterative R&D. Therefore, a specific "training set" as understood in AI/ML is not applicable to this device.

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

As noted above, a "training set" in the AI/ML sense is not applicable to this device. The development and optimization of such a rapid test involve extensive in-house analytical testing using known concentrations of analytes and interferents, which serve to refine the device design and manufacturing.

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A rapid, competitive binding immunoassay for qualitative determination of morphine in urine.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "One Step Morphine Card Test." It serves as an official notification that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, and can therefore be legally marketed.

However, the provided text does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. This letter primarily focuses on the regulatory clearance for marketing the device.

To answer your questions, I would need to review the actual 510(k) submission document (which is typically a much larger and more detailed technical document submitted by the manufacturer to the FDA), or a public summary of it, if available.

Therefore, based solely on the provided text, I cannot provide the requested information. The document is a regulatory approval letter, not a scientific study report.

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