(54 days)
qUAntify® Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. qUAntify® Plus Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
These products are a liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives.
The provided text describes the Bio-Rad Laboratories qUAntify Control and qUAntify Plus Control devices, which are urinalysis controls. It details their intended use, composition, and makes a claim of substantial equivalence to a predicate device, the Liquichek™ Urinalysis Control (K031231). The acceptance criteria are implied through the comparison of characteristics and the stability studies performed.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance of the new device relative to its predicate and its stability. The "acceptance criteria" are implied by the claims made for the new device, particularly in comparison to the predicate device and the results of the stability studies.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Monitor precision of urinalysis test procedures. | Met: "intended for use as an assayed quality control to monitor the precision of urinalysis test procedures" |
| Form | Liquid | Met: "Liquid matrix solution" |
| Storage Stability | 2°C to 8°C Until expiration date | Met: "2°C to 8°C Until expiration date" |
| Open Vial Stability | Comparable to predicate (30 days at 2-8°C or 7 days at room temp) | Exceeded: "31 days at 2 to 8°C or room temperature (18 to 25°C)" |
| Shelf Life | Not explicitly stated for predicate in comparison table, but typically long | Met: "Two years at 2 to 8 °C" |
| Matrix | Human urine for predicate | Different: "Liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives." The substantial equivalence claim suggests this difference is acceptable. |
| Analytes | Comparable analytes for urinalysis control | Broad range of analytes, largely overlapping with and in some cases expanding upon the predicate. Differences are noted but within the scope of intended use. (See full list in "Differences" section of Table 1) |
The study that proves the device meets the acceptance criteria is referred to as "Stability studies."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the qUAntify Control and qUAntify Plus Control." However, it does not specify the sample size used for these stability studies or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The controls are intended for monitoring the precision of urinalysis test procedures, and the "ground truth" would likely refer to the established, expected values for the analytes within the control materials. The document doesn't describe the process of establishing these expected values or if experts were involved in the testing for the purposes of this submission beyond the internal Bio-Rad personnel mentioned (e.g., Regulatory Affairs Specialist).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the stability studies or for establishing the expected values of the control materials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device described is a quality control material, not an imaging or diagnostic device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable in the conventional sense. This device is a quality control material used to assess the precision of urinalysis test procedures, which are typically performed by laboratory instruments or manual methods, and then interpreted by laboratory personnel. It is not an algorithm or an AI-driven device.
7. The Type of Ground Truth Used
The ground truth for a quality control material typically consists of established target values and acceptable ranges for each analyte within the control. These values are determined through extensive testing using reference methods and/or multiple clinical instruments. The document implicitly relies on this type of ground truth for its stated intended use to "monitor the precision of urinalysis test procedures."
8. The Sample Size for the Training Set
This information is not applicable/not provided. Quality control materials do not typically have "training sets" in the context of machine learning or diagnostic algorithm development. The development process involves formulation, characterization, and stability testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as #8.
§ 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.