(14 days)
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. The control is provided in liquid form for convenience. This product contains
This is a 510(k) premarket notification for a quality control material, not a medical device in the typical sense that would involve a study with human patients, performance metrics like sensitivity/specificity, or expert review. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, and ground truth for training) are not applicable.
The submission focuses on establishing substantial equivalence to a legally marketed predicate device (Quantimetrix Corporation Human Urine Control) based on similar technological characteristics and intended use. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criteria | Bio-Rad Liquichek Urine Chemistry Control (Reported Performance) | Predicate Device (Quantimetrix Human Urine Control) |
|---|---|---|
| Intended Use | An assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | A means for monitoring human urine assay methods to validate quantitation of patient samples. |
| Levels | Two | Two |
| Form | Liquid | Liquid |
| Open Vial Claim | 30 Days at 2-8°C | 24 Months at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria is primarily a comparison of technological characteristics and intended use against a legally marketed predicate device, as presented in the table above and the overall 510(k) submission. The FDA reviewed this comparison and deemed the device "substantially equivalent."
Specific Responses to Your Questions:
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Sample size used for the test set and the data provenance: Not applicable. This is a quality control material, not a diagnostic device tested on patient samples in the typical sense. The "test set" would implicitly refer to the characteristics of the control material itself, which were presumably validated internally by Bio-Rad to meet specifications, but these internal validation details are not provided in the 510(k) summary. The document does not describe patient data or clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., presence/absence of disease) is not relevant for a quality control material.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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 device is a quality control material, not an AI-powered diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical outcomes or disease. For quality control materials, "ground truth" would refer to the assigned values and stability of the analytes within the control, which are established through internal validation processes by the manufacturer. These specific data are not detailed in the 510(k) summary.
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The sample size for the training set: Not applicable. No "training set" in the context of machine learning or algorithm development is mentioned or relevant for this type of product.
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How the ground truth for the training set was established: Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.