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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 screening procedures.
Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Liquichek™ Urine Toxicology Control:
This document is a Premarket Notification (510(k)) for a medical device (a quality control material), not an AI/ML powered device. Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of submission.
The "acceptance criteria" for this device are related to its stability and performance as a quality control material, ensuring it reliably monitors laboratory toxicology screening procedures. The "study" described is a stability study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Open Vial Stability | All analytes stable for 30 days when stored tightly capped at 2-8°C. | Stability studies have been performed and support this claim. "Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C." |
| Shelf Life | 24 months when stored at 2-8°C. | Stability studies have been performed and support this claim. "24 months when stored at 2-8°C". (Note: The document states "Real time studies will be ongoing to support the shelf life," implying the 24-month claim is based on initial studies but will be further validated.) |
| Intended Use | To monitor the performance of laboratory urine toxicology screening procedures. | The device is intended for this use and is deemed substantially equivalent to a predicate device with the same intended use. The performance of the new device is considered comparable, and additional analytes (Creatinine, pH, Specific Gravity) are included, expanding its utility without altering the fundamental intended use or requiring a change in the primary performance monitoring ability. |
| Matrix | Human urine with added constituents (drugs, drug metabolites, preservatives, stabilizers). | The device is prepared from human urine with added constituents, matching the predicate device. Ensures suitability for toxicology screening. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" sample size in the context of individual urine samples for analysis because this is a quality control material itself, used to test other analytical devices.
- Sample Size for Stability Studies: Not explicitly stated as a number of replicates or batches. The document only mentions "Stability studies have been performed."
- Data Provenance: The studies were conducted by Bio-Rad Laboratories, the manufacturer. The data is retrospective in the sense that the studies were completed prior to the 510(k) submission, but the "real time studies will be ongoing" for shelf life suggest a prospective element to continuous monitoring of product stability. There is no mention of country of origin of the data in terms of patient samples, as it's a control material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a biochemical control material. Its "ground truth" (the expected concentration of analytes, its stability characteristics) is established through analytical chemistry methods during formulation and stability testing, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method in the traditional sense (e.g., for clinical diagnoses) for a quality control product. The "truth" of its composition and stability is determined by standardized laboratory methods and analytical instrumentation.
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. This is not an AI/ML device, nor is it a diagnostic tool where human readers would be involved in interpreting results in the context of aiding human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or an AI device. It's a laboratory reagent/control.
7. The Type of Ground Truth Used
The ground truth for the composition of the Liquichek™ Urine Toxicology Control (i.e., the presence and concentration of analytes) is established through analytical chemistry methods and formulation specifications. For stability, the ground truth is determined by measuring analyte concentrations over time under specified storage conditions using validated analytical methods. This is essentially a form of analytical or laboratory-determined truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device.
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