(49 days)
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse, metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. 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 Liquichek Urine Toxicology Control (Confirmatory Series):
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria in the typical sense for a new diagnostic assay. However, we can infer the performance aspects that were considered and claimed by the manufacturer.
| Performance Characteristic | Acceptance Criteria (Implicit/Claimed) | Reported Device Performance |
|---|---|---|
| Intended Use | To monitor the performance of laboratory urine toxicology confirmatory procedures. | Device is intended for this use, matching the predicate. |
| Form | Liquid | Liquid form, matching the predicate. |
| Matrix | Urine | Urine matrix, matching the predicate. |
| Storage (Unopened) | Stable until expiration date at 2 to 8°C. | 3 Years at 2 to 8°C (Shelf Life). |
| Open Vial Stability | All analytes stable for 30 days when stored tightly capped at 2 to 8°C. | 30 days at 2 to 8°C. |
| Analytes Present | Must contain specific drugs of abuse and metabolites, including the newly added MDMA, MDA, and MDEA (in C2, C3, C4). | Contains all listed analytes, including the new MDMA, MDA, and MDEA. |
| Comparability | Similar to the predicate device in intended use, form, matrix, and storage conditions, with the specified addition of new analytes. | Demonstrated similarity to predicate device (K021384). |
Note: The document does not provide specific quantitative acceptance limits (e.g., +/- 10% from target concentration) for the control's performance when monitoring confirmatory procedures. The substantiation focuses on the stability and formulation of the control material itself.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of device performance data (e.g., clinical samples). The studies performed relate to the stability of the control material, not its performance against patient samples.
- Data Provenance: The document states "All supporting data is retained on file at Bio-Rad Laboratories." There is no mention of country of origin or whether the data is retrospective or prospective, though stability studies are generally prospective by nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to the provided document. The device is a quality control material, not a diagnostic device that interprets patient data. Therefore, there is no "ground truth" established by experts in the context of patient diagnosis. The "ground truth" for this device would be the accurately known concentrations of the analytes within the control material, which is established during its manufacturing and characterization process by the manufacturer (Bio-Rad Laboratories).
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. There is no expert adjudication for a quality control material.
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. The device is a quality control material, not an AI-powered diagnostic tool, and it does not involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical quality control material, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device is the known, established concentrations of the specific drug analytes and their metabolites within the control material. This is determined through the manufacturing and analytical characterization processes of Bio-Rad Laboratories.
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 diagnostic algorithm development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8. The "ground truth" for the control material is inherent to its formulation and analytical characterization.
§ 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.