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One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, or Tricyclic Antidepressants are ingested, at prescribed to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine, or Tricyclic Antidepressants in urine.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) or an equivalent analytical method is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding , lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Morphine, Propoxyphene, Tri-cyclic Antidepressants and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

Here's a breakdown of the acceptance criteria and study details for the One Step Single/Multi-drug Test Cup and Dipcard, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for overall device performance (e.g., global sensitivity/specificity targets). Instead, the performance data is presented against the established cutoff concentrations for each drug. The implicitly accepted performance is demonstrated by the agreement between the device's results and the confirmatory methods (GC/MS or HPLC) across different concentration ranges.

The tables below synthesize the performance of the device (both Cup and Dipcard formats, for Single and Multi-drug tests) by showing how results align with concentrations relative to the cutoff. The provided data focuses on the distribution of results across different concentration categories rather than overall accuracy metrics like sensitivity or specificity. However, we can infer performance by observing the agreement rates within each category.

Inferred Acceptance Criteria:
The device is expected to:

• Consistently produce negative results for drug-free samples.
• Consistently produce negative results for samples significantly below the cutoff concentration (less than half the cutoff).
• Demonstrate appropriate discrimination around the cutoff, with increasing positive results as concentrations approach and exceed the cutoff.
• Show agreement with confirmatory methods (GC/MS or HPLC) for samples within and outside the cutoff ranges.

Reported Device Performance (Sample Summary for BUP from 'Single drug Test' and 'Multi-drug Test' for both Cup and Dipcard):

Since the results are identical across all provided tables for BUP, EDDP, MOP, PPX, and TCA for both Single/Multi-drug Test Cup and Dipcard, a representative row is used.

Buprenorphine (BUP) Performance (Representative Example):

• Calibrator: Buprenorphine
• Cutoff Level: 10 ng/mL

Discordant Results (Representative Example for BUP):

• BUP Test: Positive result at 7.8 ng/mL (below 10 ng/mL cutoff). This is a false positive based on the cutoff but within the expected variability around the cutoff.
• TCA Test: Negative result at 1138 ng/mL (above 1000 ng/mL cutoff). This is a false negative.

(Similar tables and discordant results exist for EDDP, MOP, PPX, and TCA, exhibiting comparable patterns.)

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

• Sample Size: 80 clinical urine specimens were used for each drug (BUP, EDDP, MOP, PPX, TCA) for each device type (Single drug Test Cup, Single drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). This means:
  • Single drug Test Cup: 5 drugs * 80 specimens = 400 specimens
  • Single drug Test Dipcard: 5 drugs * 80 specimens = 400 specimens
  • Multi-drug Test Cup: 5 drugs * 80 specimens = 400 specimens
  • Multi-drug Test Dipcard: 5 drugs * 80 specimens = 400 specimens
  • Total specimens analyzed across all tests and drugs: 1600 individual drug/specimen analyses.
• Data Provenance: The document states "80 clinical urine specimens". It does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

The ground truth was established by analytical methods, not human experts.

• Number of Experts: Not applicable, as ground truth was not established by human experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The ground truth was established by definitive analytical methods, not through an adjudication process involving human interpretation of the device results.

• Adjudication Method: Not applicable. The reference method (GC/MS or HPLC) served as the definitive ground truth.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described or performed. This device is an in-vitro diagnostic assay for qualitative drug detection in urine, primarily evaluated against gold-standard analytical methods rather than against human readers or human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Yes, the performance data presented is for the device's standalone performance. The "Co-Innovation Result" recorded for each specimen is directly from the device (visual interpretation of the test line on the Cup/Dipcard), without human intervention in interpreting the results. The comparison is made against laboratory-confirmed concentrations, representing the device's intrinsic analytical performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: Analytical confirmation methods:
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • High-Performance Liquid Chromatography (HPLC)

8. The Sample Size for the Training Set

The document describes performance studies (accuracy, precision, sensitivity, specificity/cross-reactivity, interference, stability, and home-use consumer study), but it does not specify a separate "training set" or "training data" used for algorithm development, as this device appears to be a lateral flow immunoassay, not a machine learning-based device.

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

As there is no mention of a "training set" for an algorithm, this question is not applicable. For quality control during manufacturing and development, external controls and reference materials are typically used, but these are not equivalent to an algorithm's training set in the context of AI/ML.

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One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the Co-Innovation Biotech Co.,Ltd. One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard for qualitative detection of drugs of abuse in human urine. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay tests like these are typically assessed by comparing the device's results (positive/negative) against a gold standard (GC/MS) especially around the cutoff concentration. While explicit numerical acceptance criteria (e.g., % agreement, sensitivity, specificity targets) are not explicitly stated as 'acceptance criteria' in the document, the performance data implicitly serves as the demonstration that the device performs acceptably. The study evaluates the device's ability to correctly identify drug-free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive samples.

The tables below synthesize the reported device performance for both the Test Cup and Test Dipcard formats for single and multi-drug tests, against the GC/MS analysis. The "Total" column in the original tables sums up the sample distribution across concentration categories, not the total number of samples processed for each drug test condition. The key performance indicator here is the consistency of results, particularly for samples around the cutoff concentration.

Device Performance for One Step Single/Multi-drug Test Cup & Dipcard (Single Drug Test Example - All Drugs follow similar pattern)

| Drug Test | Co-Innovation Result | GC/MS Analysis (Drug-free) | GC/MS Analysis (1.5x Cutoff) | Total Samples |
|---|---|---|---|---|---|---|---|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | 80 |

Analysis of Discordant Results (Example for Test Cup and Dipcard, Single and Multi-drug)

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

• Sample Size: 80 clinical urine specimens were used for each drug tested, for each device format (Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). Therefore, for each drug, a total of 320 samples were analyzed (80 * 4). The samples were categorized into five groups based on concentration relative to the cutoff (drug-free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive).
• Data Provenance: The data is from "clinical urine specimens," implying human origin. However, the country of origin is not specified, and it is a retrospective analysis as the specimens were analyzed by GC/MS for comparison with the device.

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

• The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "preferred confirmatory method" for drug of abuse testing.
• No human "experts" are mentioned as having established the ground truth through consensus or individual reading of the device results for the purpose of the primary accuracy study. The device results were compared directly against the GC/MS findings.

4. Adjudication Method for the Test Set

• None in the traditional sense of multiple human readers adjudicating results. The device's qualitative results (positive/negative) were directly compared to the quantitative GC/MS results for each sample. Discordant results were individually listed with the GC/MS concentration.

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

• No, a MRMC comparative effectiveness study was not performed. The study's focus was on the standalone performance of the devices against a gold standard (GC/MS). Human readers' improvement with or without AI assistance is not relevant here as it's a diagnostic test that provides a clear positive/negative result, not an AI-assisted diagnostic imaging interpretation.

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

• Yes, this was a standalone performance study. The "One Step Single/Multi-drug Test Cup" and "One Step Single/Multi-drug Test Dipcard" are qualitative, lateral flow immunochromatographic assays designed to be read directly without an instrument or human interpretation loop beyond reading the presence or absence of test lines. The performance data presented directly reflects the device's output (positive/negative) compared to GC/MS.

7. The Type of Ground Truth Used

• The ground truth used was quantitative analytical data from Gas Chromatography/Mass Spectrometry (GC/MS), which is the preferred confirmatory method for drug of abuse testing. This is a highly objective and precise method for determining drug concentration.

8. The Sample Size for the Training Set

• This document describes a performance evaluation of a medical device, not an AI algorithm that requires a training set. Therefore, no training set for an algorithm is mentioned or applicable in this context. The devices are immunoassay tests, not machine learning algorithms.

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

• As mentioned above, there is no training set for an algorithm as the device is an immunoassay test.

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One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:

Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 50 ng/ml.
Cocaine (COC) Benzoylecgonine 300 ng/ml.
Amphetamine (AMP) D-Amphetamine 1000 ng/ml.
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 2000 (MOP) Morphine 2000 ne/ml.

The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.

These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the performance of the Co-Innovation Biotech Co., Ltd. One Step Single/Multi-drug Test Cup and Dipcard for the qualitative detection of drugs and drug metabolites in human urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance metrics (like sensitivity, specificity, or agreement percentages). Instead, it presents the results of clinical studies (accuracy studies) designed to demonstrate the device's performance against a gold standard (GC/MS). The implied acceptance is that the device demonstrates a high level of agreement with GC/MS, especially near and above the cutoff concentrations.

For the purpose of this response, I infer the performance target is to achieve high agreement with GC/MS. The reported device performance is shown in the tables below, demonstrating the number of positive and negative results from the device compared to GC/MS at different concentration levels.

Performance Summary (based on provided data for both formats: Cup and Dipcard)

| Drug Test | Cut-off Level (ng/mL) | Device Format | Agreement with Drug Free (Negative Result) | Agreement with

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