(37 days)
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience.
This document is a 510(k) summary for the Bio-Rad Liquichek Urine Toxicology Control, a quality control urine intended to monitor the performance of laboratory urine toxicology screening procedures. It does not provide information about a study that assesses the performance of a device against acceptance criteria in the manner described in the request.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The document focuses on demonstrating substantial equivalence to existing predicate devices (Liquid Drugs of Abuse Controls, Medical Analysis Systems, K903430), rather than outlining performance against specific acceptance criteria for a new device's functionality. The tables within the document compare the technological characteristics and intended use of the Bio-Rad product to the predicate device, which is a different type of evaluation from a performance study.
§ 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.