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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)

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

• Single Drug Test:
  • Test Set Size: 165-186 clinical urine specimens for each drug (AMP, COC, THC, MET, MOP) were used for each device format (Cup and Dipcard).
  • Data Provenance: The specimens were described as "clinical urine specimens," implying they were collected from human subjects in a real-world clinical setting. No specific country of origin is mentioned, but the submitter's address is in Guangzhou, P.R. China, suggesting the data may originate there. The study appears to be retrospective, as existing clinical specimens were analyzed.
• Multi-Drug Test:
  • Test Set Size: 80 clinical urine specimens for each drug were used for each device format (Cup and Dipcard).
  • Data Provenance: Similar to the single drug test, these were "clinical urine specimens." Provenance details are identical to the single drug test.

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). This is a laboratory-based analytical method, not a human expert interpretation. Therefore, the concept of "number of experts" or their "qualifications" in the context of establishing ground truth does not apply as it would for image-based diagnostics. The accuracy of GC/MS itself is well-established as a confirmatory method for drug testing.

4. Adjudication Method for the Test Set

No human adjudication method (like 2+1, 3+1 consensus) was used. The study compared the device results directly against the quantitative results obtained from GC/MS. Discordant results (where the device and GC/MS disagreed) are individually listed with the specific drug concentration from GC/MS. This suggests that GC/MS was considered the definitive gold standard.

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

No MRMC comparative effectiveness study was done. This device is a biochemical assay (lateral flow immunoassay) for qualitative detection, not an AI-assisted diagnostic tool where human readers interpret medical images or data. The device provides a direct positive/negative result, not an interpretation that humans would then review.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was effectively a standalone study. The device (One Step Single/Multi-drug Test Cup/Dipcard) itself produces a result (qualitative positive or negative) without human interpretation. The study evaluates the performance of the device only against the GC/MS ground truth. Human involvement is limited to performing the test procedure and reading the physical test line, which is a direct visual cue, not an interpretive task that would significantly affect the "algorithm's" performance.

7. The Type of Ground Truth Used

The ground truth used was GC/MS Analysis (Gas Chromatography/Mass Spectrometry). This is an objective, analytical method that provides quantitative drug concentrations in the urine specimens. It is considered the gold standard for drug confirmation.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device. As an immunochromatographic assay, these devices are typically developed through bench-top experimentation and optimization of reagents and manufacturing processes, rather than machine learning training that would require a distinct "training set." The performance data provided is for the rigorous testing of the finalized device.

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

Since there is no explicit training set mentioned in the context of machine learning, this question is not directly applicable. The development and optimization of the immunoassay itself would rely on established biochemical principles and analytical methods to determine antigen-antibody reactions and cutoff sensitivities, likely using reference standards and known concentrations of drugs and metabolites during the R&D phase.

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