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Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.

Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

The provided text details a 510(k) summary for the Bio-Rad Liquichek Urine Toxicology Control, primarily focusing on establishing substantial equivalence to a predicate device. This type of submission, particularly from 1997, predates the extensive and detailed performance study requirements often seen in more recent AI/ML device submissions.

Therefore, the document does not contain the acceptance criteria and a study proving the device meets those criteria in the way you've outlined for AI/ML devices.

Here's why and what information can be extracted:

1. A table of acceptance criteria and the reported device performance:

• No explicit acceptance criteria or reported performance metrics are provided. The document focuses on comparing the technological characteristics of the new device to a predicate device to establish substantial equivalence. This is a comparison of features and intended use, not a performance evaluation against specific criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not applicable / Not provided. The document describes a "control" product for monitoring other diagnostic tests. It isn't a diagnostic device itself that processes a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable / Not provided. As it's a quality control product, the concept of "ground truth" for patient data or expert interpretation doesn't apply to the device's own performance evaluation as described. The "truth" for this device is its known concentration of drugs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable / Not provided.

5. 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:

• Not applicable / Not provided. This is a quality control product, not an AI/ML-powered diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not provided. Not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the control itself, the "ground truth" is inherent to its manufacture: known concentrations of drugs and drug metabolites added to human urine. The document states it is "prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers."

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable / Not provided.

Summary of Relevant Information from the Document:

The provided document is a 510(k) summary for a quality control product, not a diagnostic device that processes patient data or uses AI/ML. Its purpose is to monitor the performance of other laboratory urine toxicology screening procedures.

The "study" presented is a comparison of technological characteristics to a legally marketed predicate device (K903430 - Liquid Drugs of Abuse Controls Medical Analysis Systems) to demonstrate substantial equivalence, rather than a performance study with acceptance criteria against patient samples.

Key comparisons for substantial equivalence:

• Intended Use: Both are quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
• Levels: Both have similar concepts for drug concentrations relative to immunoassay cutoffs (e.g., 20-25% below, 20-25% above, elevated).
• Form: Liquid
• Matrix: Human Urine
• Storage: 2-8°C
• Open Vial Claim: 30 Days at 2-8°C

The FDA's letter (K971691) confirms the finding of substantial equivalence based on this comparison.

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