(27 days)
A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Liquichek™ Urine Toxicology Control Levels C1, C2, C3 and C4 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4:
1. Table of Acceptance Criteria and Reported Device Performance
The submission form for the Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4 is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo acceptance criteria and proving performance against them in the same way a PMA submission might.
Therefore, the "acceptance criteria" for this device are largely implicit in its comparison to the predicate device and the demonstration of stability. The "reported device performance" primarily relates to its stability under various conditions.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Monitor performance of laboratory urine toxicology confirmatory procedures (same as predicate). | The device's intended use is identical to the predicate device. |
| Form Equivalence: Liquid form (same as predicate). | The device is provided in liquid form. |
| Matrix Equivalence: Human urine matrix (same as predicate). | The device is prepared from human urine. |
| Open Vial Stability: Stable for 30 days when stored tightly capped at 2-8°C. | Open vial stability: 30 days when stored at 2-8°C. |
| Shelf Life Stability: Stable for the declared shelf life when stored at 2-8°C. (Initial claim: 24 months). | Shelf life: 24 months when stored at 2-8°C. (Real-time studies ongoing). |
| Performance in Toxicology Confirmatory Procedures: Function effectively as a quality control for the listed analytes (implied by intended use and comparison to predicate). | The device includes the same analytes as the predicate, plus additional claims for Creatinine, pH, and Specific Gravity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the stability studies or provide details on the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Stability studies have been performed" and "All supporting data is retained on file at Bio-Rad Laboratories."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a quality control material like this, "ground truth" for stability would typically be established through analytical testing against known reference materials or validated methods, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods (like 2+1 or 3+1) are typically used for diagnostic studies involving human interpretation or subjective assessments, which is not directly applicable to the stability testing of a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for evaluating the impact of a device on human reader performance, which doesn't apply to a quality control material.
6. Standalone Performance Study
The focus of the submission is demonstrating substantial equivalence to a predicate device and proving the stability of the new device. The "performance" studies described are the stability studies. These are inherently standalone tests of the device's characteristics (e.g., concentration of analytes over time).
7. Type of Ground Truth Used
For the stability studies, the "ground truth" would be the analytical measurement of the analytes within the quality control material over time, compared to established reference values or specifications for stability. The document does not explicitly detail the methods used to establish these reference values, but it's implied to be internal analytical validation.
8. Sample Size for the Training Set
This product is a quality control material, not an algorithm or diagnostic model that requires a "training set" in the machine learning sense. Therefore, there is no training set mentioned or applicable for this device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.