(44 days)
Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Liquichek Urine Toxicology Control is 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.
The provided document is a 510(k) premarket notification for a quality control device, not a diagnostic device with performance metrics typically found in clinical studies. Therefore, many of the requested fields are not applicable.
Here's the breakdown of the information that can be extracted and explanations for what isn't applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Monitor the performance of laboratory urine toxicology confirmatory procedures (same as predicate). | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. (Matches predicate) |
| Form | Liquid (same as predicate). | Liquid (Matches predicate) |
| Matrix | Urine (same as predicate). | Urine (Matches predicate) |
| Storage | 2-8°C until expiration date (same as predicate). | 2-8°C until expiration date (Matches predicate) |
| Open Vial | 30 days at 2-8°C (same as predicate). | 30 days at 2-8°C |
| Drugs | Contains drugs consistent with monitoring urine toxicology confirmatory procedures (similar to predicate, with additions). | Contains all drugs present in the predicate device (d-Amphetamine, d-Methamphetamine, Secobarbital, Amobarbital, Butalbital, Pentobarbital, Phenobarbital, Nordiazepam, α-hydroxyalprazolam, 11-Nor-Δ-9-THC-9-COOH, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-D-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine, Specific Gravity, pH) |
| Additionally, contains: MDMA, MDA, MDEA | ||
| Shelf Life | Not explicitly stated as acceptance criteria, but stability studies support a shelf life of 3 years at 2-8°C for the predicate. | Three years stored at 2-8°C (Supported by stability studies). Real-time studies are ongoing. |
Explanation of Device Performance: The "device performance" for this quality control material is its ability to remain stable and effectively serve its intended purpose (monitoring the performance of toxicology tests) over specified periods. The data presented primarily addresses stability.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document describes a quality control product, not a diagnostic test evaluated on human samples. The "studies" were stability studies on the product itself.
- Data Provenance: The stability studies were conducted by Bio-Rad Laboratories. The provenance of the human urine used for manufacturing the control is not specified, but the "data" itself relates to the control product's stability. Both open vial and shelf life studies were performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of disease status or clinical outcome, is not relevant for a quality control material.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication. The performance data is based on stability testing of the 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
- Not applicable. This is not an AI-powered diagnostic device, and no human reader studies were conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical quality control material, not an algorithm.
7. The type of ground truth used
- Not applicable in the conventional sense of a clinical ground truth. The "ground truth" for this device revolves around its chemical composition and stability specifications, which are determined during manufacturing and validated through analytical testing.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.