(61 days)
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.
Liquichek™ Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided text describes the Liquichek™ Urinalysis Control device and its substantial equivalence to a predicate device, focusing on its intended use as an assayed quality control urine to monitor the precision of urinalysis test procedures.
However, the document does not contain the level of detail typically found in a clinical study report that would establish acceptance criteria and prove the device meets them in the context of diagnostic accuracy, which is what your questions imply.
Instead, this document focuses on demonstrating substantial equivalence to a previously approved device (K965171), primarily through comparison of characteristics and stability studies for the control material itself.
Therefore, for most of your questions, the information is not available in the provided text. I will answer what can be inferred or directly stated from the document, and indicate "Not Applicable" or "Not Provided" where the information is absent or does not fit the context of this type of submission.
Acceptance Criteria and Device Performance for Liquichek™ Urinalysis Control
The acceptance criteria for this device are aligned with demonstrating its performance as a quality control material for monitoring the precision of urinalysis test procedures. The study described focuses on establishing the stability of the control material over time, both when sealed (shelf life) and after opening (open vial stability), which are critical performance aspects for a quality control product.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for a Quality Control Material) | Reported Device Performance (from "Statement of Supporting Data") |
|---|---|
| Open Vial Stability: Maintain stability of all analytes after opening for a defined period. | 30 days at 2 to 8°C, or 7 days at room temperature (18 to 25°C), when stored tightly capped. |
| Shelf Life: Maintain stability of all analytes for a defined period when stored as directed. | 30 months when stored at 2 to 8°C. (Note: "Real time studies will be ongoing to support the shelf life of this product" indicates this is an initial claim based on accelerated or partial real-time data.) |
| Equivalence to Predicate Device: Similar intended use, form, matrix, storage, and analytes (with additions). | Demonstrated through comparative table (Section 6.0) and FDA's substantial equivalence determination. Additions include Creatinine and Protein-Creatinine Ratio. |
| Precision Monitoring: Ability to monitor the precision of urinalysis test procedures. | This is the intended use of the device, and its efficacy is assumed based on its nature as a quality control material and substantial equivalence to a predicate device already performing this function. No specific precision monitoring numerical performance (e.g., CV%) is given for the control material itself. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of number of runs or batches for the stability studies. The stability studies are typically performed on a selection of manufactured lots.
- Data Provenance: The studies were performed by Bio-Rad Laboratories, located in Irvine, California. The data would be considered prospective as it involves controlled stability testing of the newly formulated product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For a quality control material, "ground truth" typically refers to the established target values and acceptable ranges for the analytes within the control. These are determined through extensive analytical testing and statistical analysis by laboratory personnel, not by clinical experts for diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in diagnostic studies where human readers interpret medical images or clinical data and their interpretations need to be reconciled. This document describes the performance of a laboratory quality control material, not a diagnostic device involving human interpretation of patient data.
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 a quality control material, not an AI-assisted diagnostic device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm or an automated diagnostic system. Its "standalone" performance relates to its inherent stability and accuracy as a reference material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" (or reference values) for its analytes are established through highly characterized analytical methods and statistical analysis of multiple measurements. This is typically done in-house by the manufacturer's analytical chemistry and quality control departments using reference methods and calibrated instruments. This is not driven by expert clinical consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. The concept of a "training set" applies to machine learning algorithms or AI models. This device is a biochemical control material, not an AI product.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this quality control material.
§ 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.