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Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.

Liquichek Qualitative Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers, and constituents of animal origin. The control is provided in liquid form for convenience.

Here's a breakdown of the acceptance criteria and study information for the Liquichek Qualitative Urine Toxicology Control, based on the provided text:

Important Note: The provided document is a 510(k) summary for a clinical toxicology control material. These types of devices (quality controls) are not typically evaluated in the same way as diagnostic devices for patient care. They do not involve human-in-the-loop studies, ground truth establishment by medical experts for diagnostic accuracy, or multi-reader multi-case studies. Their performance is primarily assessed through stability testing to ensure they maintain their intended characteristics over time.

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study involved stability testing to determine the open vial stability and shelf life of the Liquichek Qualitative Urine Toxicology Control.

Additional Information on the Study:

1. Sample size used for the test set and data provenance:
   This information is not explicitly provided in the summary. For stability studies, "samples" would refer to batches of the control material tested over time. The document states "All supporting data is retained on file at Bio-Rad Laboratories," indicating the data ownership, but details on the number of batches or individual control units tested are absent. Data provenance is implied to be from Bio-Rad Laboratories' internal testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable for a quality control device. The "ground truth" for a quality control is its known concentration or qualitative presence/absence of analytes, established during manufacturing and validated through analytical testing, not by expert medical review.

3. Adjudication method for the test set:
   This is not applicable for a quality control device. Adjudication methods like 2+1 or 3+1 are used for diagnostic studies involving human interpretation of results, not for the analytical performance of a control material.

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:
   No, an MRMC comparative effectiveness study was not done. This type of study relates to diagnostic aids, particularly those with AI components, and is not relevant for a quality control product.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   No, a standalone algorithm performance study was not done. This device is a biochemical control material, not a software algorithm.

6. The type of ground truth used:
   The "ground truth" for this control material would be the known, manufactured concentrations or qualitative presence/absence of the specific drugs and metabolites added to the human urine matrix. This is established through the manufacturing process and confirmed by analytical methods, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:
   This is not applicable. This device is a physical control material, not a machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established:
   This is not applicable as there is no training set for this type of device.

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