(11 days)
Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.
Liquichek Qualitative Urine Toxicology Controls are prepared from human urine with added drugs of abuse and 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 information, structured to address your specific requests.
This document describes a quality control product, not an AI/ML medical device. Therefore, several of the requested sections (e.g., MRMC studies, standalone algorithm performance, AI assistance) are not applicable.
Acceptance Criteria and Study for Liquichek Qualitative Urine Toxicology Control (K052053)
This submission is for a quality control material rather than a diagnostic device that performs analysis. As such, the "acceptance criteria" and "device performance" relate to the stability and composition of the control material itself, ensuring it functions as intended for monitoring laboratory procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | All analytes stable for 30 days when stored tightly capped at 2-8°C or 18-25°C. | The statement directly claims: "All analytes will be stable for 30 days when stored tightly capped at 2 to 8°C or 18 to 25°C." This indicates the device met this performance claim based on internal studies. |
| Shelf Life | All analytes stable for 3 years at 2-8°C. | The statement directly claims: "3 Years at 2 to 8°C." This indicates the device met this performance claim based on initial studies, with real-time studies ongoing. |
| Traceability/Ground Truth | The control material contains specified drugs of abuse and metabolites at known concentrations to act as a positive or negative control. The Reported Device Performance refers to the characteristics of the formulated control material, which itself serves as a "ground truth" for the assays it monitors. | The control is "prepared from human urine with added drugs of abuse and metabolites...". The new device adds Oxycodone to the existing panel of drugs (Amphetamines, Barbiturates, Benzodiazepines, Benzoylecgonine, Cannabinoids, Cocaine, d-Amphetamine, d-Methamphetamine, Ethanol, LSD, MDMA, Methadone, Methaqualone, Morphine (Free), Nordiazepam, Nortriptyline, Opiates, Oxazepam, Phencyclidine, Propoxyphene, Secobarbital, Tricyclic Antidepressants (TCA)). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The studies referenced are stability studies of the physical control product itself, not diagnostic tests on patient samples. The "test set" would refer to control vials tested over time and under various conditions.
- Data Provenance: The studies were "performed to determine the open vial stability and shelf life for the Liquichek Qualitative Urine Toxicology Control." This indicates prospective, internal testing conducted by Bio-Rad Laboratories. The country of origin is implied to be within the US, given Bio-Rad's address in California.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a quality control material, not a diagnostic or AI device requiring expert interpretation for ground truth. The "ground truth" for a quality control material is its precisely manufactured composition and stability characteristics, determined by chemical analysis and stability protocols.
4. Adjudication Method for the Test Set
This is not applicable for a quality control material stability study. Adjudication methods are typically used when human interpretation of data (e.g., medical images, clinical findings) is involved in establishing ground truth or comparing performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable as the device is a quality control material, not an AI/ML diagnostic system or a system that aids human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this product is its manufactured composition and confirmed stability characteristics. The control material itself is formulated to contain specific analytes (drugs of abuse and their metabolites) at known concentrations. The stability studies (shelf life and open vial) then confirm that these known concentrations remain stable under storage conditions, ensuring the integrity of the "ground truth" over time.
8. The Sample Size for the Training Set
This is not applicable. Quality control materials do not typically have "training sets" in the context of machine learning or diagnostic algorithm development. The "design and formulation" of the control material is based on chemical and manufacturing principles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as above. The composition of the control material is established during its manufacturing process using validated analytical methods to ensure the concentrations of added substances are accurate.
§ 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.