(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, 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.
| Acceptance Criteria (Implied by Study Claims) | Reported Device Performance |
|---|---|
| Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2-8°C. | Successfully demonstrated stability for 30 days at 2-8°C. |
| Shelf Life: All analytes stable for 24 months when stored at 2-8°C. | Successfully demonstrated stability for 24 months at 2-8°C (with ongoing real-time studies). |
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.
§ 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.