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

Liquichek™ Urine Toxicology Control Levels S1, S2 and S3 are prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers. The control is provided in liquid form for convenience.

The provided document describes the safety and effectiveness of the Liquichek™ Urine Toxicology Control Levels S1, S2, and S3. This product is a quality control urine intended to monitor the performance of laboratory urine toxicology screening procedures.

The study primarily focuses on demonstrating the stability and shelf life of the device rather than a direct performance comparison against an external standard or clinical outcome. The acceptance criteria and "device performance" in this context refer to the product's ability to maintain its specified characteristics over time under various storage conditions.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not present "acceptance criteria" in a typical quantitative clinical trial sense (e.g., sensitivity, specificity, accuracy against a gold standard) for a diagnostic device. Instead, it focuses on the stability of the control material over time. The "performance" is the successful demonstration of these stability claims.

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

• Sample Size for Test Set: The document does not explicitly state the number of individual control vials or batches tested in the stability studies. It broadly states "Stability studies have been performed."
• Data Provenance: Not explicitly stated. The studies were conducted by Bio-Rad Laboratories, likely internally. The country of origin of the data is not specified, nor is whether the data is retrospective or prospective, though "real-time studies will be ongoing" for shelf-life suggests prospective data collection.

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

• Number of Experts: Not applicable. This device is a quality control material, not a diagnostic test requiring expert interpretation of results to establish ground truth. The "ground truth" for the stability studies would be the known concentration of analytes in the control material and their measured concentrations over time.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The studies performed are chemical stability studies of a control material rather than an evaluation requiring clinical adjudication.

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

• Was an MRMC study done? No. This type of study is not relevant for a quality control material.

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

• Was a standalone study done? This question is not directly applicable in the typical sense for an "algorithm." However, the stability studies can be considered "standalone" in that they evaluate the intrinsic characteristics of the control material (analyte concentration over time) without human interpretation being the primary variable. The performance measured is the physical/chemical stability of the product itself.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the stability studies is analytical measurements of analyte concentrations over time. The "ground truth" concentrations for the control material are established during its manufacture and characterized by Bio-Rad Laboratories. The stability studies then monitor if these known concentrations remain within acceptable limits. There is no "expert consensus," "pathology," or "outcomes data" involved in establishing the ground truth for this type of product's stability.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This product is a quality control material, not an AI/ML algorithm that requires a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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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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