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510(k) Data Aggregation
(26 days)
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Liquichek 14 Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate is 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. This product contains 0.1% sodium azide as a preservative.
The provided text describes a 510(k) premarket notification for a medical device, the Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate. This type of notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria in the same way a novel device might.
Therefore, the document does not contain the typical information one would expect for acceptance criteria of a diagnostic algorithm or AI system, nor does it describe a study proving the device meets such criteria with respect to diagnostic performance (e.g., sensitivity, specificity, accuracy).
Instead, the "acceptance criteria" for this device relate to its intended use as a quality control material and its stability, demonstrating that it performs similarly to the predicate device.
Here's an analysis of the provided text based on your request, interpreting "acceptance criteria" in the context of a quality control product:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding performance data for diagnostic accuracy. Instead, the performance data focuses on stability, which is a key characteristic for a quality control material.
| Characteristic | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Maintain stability for analytes for a defined period after opening. | 30 days when stored tightly capped at 2-8°C. |
| Shelf Life | Maintain stability for analytes for a defined period when unopened. | 24 months when stored at 2-8°C. |
| Intended Use | Function as a quality control urine to monitor laboratory urine toxicology confirmatory procedures. | Stated as the intended use, and substantial equivalence to a predicate device with the same intended use is claimed. No performance metrics for this are provided, except by reference to the predicate. |
| Matrix | Human urine with added constituents, similar to predicate. | Human urine, same as predicate. |
| Form | Liquid, similar to predicate. | Liquid, same as predicate. |
| Storage (Unopened) | 2-8°C, similar to predicate. | 2-8°C until expiration date, same as predicate. |
| Storage (Open Vial) | 2-8°C for 30 days, similar to predicate. | 2-8°C for 30 days, same as predicate. |
| Analytes | Contain specific analytes, including "Low Opiate" levels, and additional claims for Creatinine, pH, and Specific Gravity. | Contains specified analytes at C2 Low Opiate (20-25% below cutoff) and C3 Low Opiate (20-25% above cutoff) levels, plus Creatinine, pH, and Specific Gravity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Stability studies" were performed. However, it does not provide:
- The sample size (e.g., number of vials, number of measurements).
- The data provenance (country of origin).
- Whether the studies were retrospective or prospective, although "Real time studies will be ongoing" suggests prospective data collection for shelf life.
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)
This information is not applicable to this document. The device is a quality control material, not a diagnostic algorithm that requires expert ground truth for imaging or other diagnostic interpretations. Its "performance" is about its chemical stability and concentration levels, which are determined by laboratory means, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used to establish ground truth in diagnostic studies, particularly when multiple experts are involved. For chemical stability testing of a quality control product, laboratory methods and instrument readings determine the results.
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
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, typically in reading medical images or complex diagnostic data. This device is a quality control material and does not involve human "readers" interacting with an AI system for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device relates to the known concentration of analytes within the control material and its stability over time. This is established through internal laboratory testing and analytical chemistry methods, where the concentrations are intentionally set and then verified. It's not based on expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
This information is not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI algorithms. The product's composition and stability are determined through manufacturing processes and analytical testing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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