(28 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 the 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 is related to the submission of a medical device for FDA approval (510(k) premarket notification) and does not describe acceptance criteria, performance studies, or efficacy data in the typical sense for a diagnostic algorithm or advanced medical device.
The "device" in question is the "Liquichek™ Urinalysis Control," which is a quality control solution for laboratory urinalysis tests. The purpose of this submission is to demonstrate substantial equivalence to a previously approved control solution, with the only addition being claims for "color and clarity."
Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training, etc.) are not applicable in this context. The study described is a stability study for the control solution itself, not a study evaluating the performance of a diagnostic device against a clinical outcome or expert consensus.
Here's an attempt to answer the questions based on the provided text, noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a quality control material and not a diagnostic device, the "performance" relates to its stability. The acceptance criteria essentially define the stability required for its intended shelf life and open-vial use.
| Acceptance Criteria (Internal) | Reported Device Performance (Stability) |
|---|---|
| Open vial stability requirement | All analytes stable for 30 days at room temperature (18 to 25°C) when tightly capped. |
| Shelf life stability requirement | 30 months (when stored at 2 to 8°C). |
Note: The document states "All supporting data is retained on file at Bio-Rad Laboratories" and "Real time studies will be ongoing to support the shelf life of this product." This implies the "reported device performance" in terms of stability is based on conducted studies, but the specific raw data or detailed performance metrics (e.g., drift, acceptable range of variation) are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable in the context of an algorithm or diagnostic device. For the stability studies of the control solution, the "sample size" would refer to the number of lots or vials tested over time. This information is not provided in the summary. The studies are prospective in nature, as they involve monitoring the product over time. The country of origin of the data is Bio-Rad Laboratories (Irvine, California, USA).
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. The "ground truth" for a quality control solution would be its known chemical and physical properties at different time points, measured by laboratory instrumentation, not expert human evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication is used for interpreting ambiguous clinical data, which is not relevant here.
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 device is a quality control solution, not an AI-powered diagnostic tool, and involves no human readers or AI assistance in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "performance" is the inherent stability of the chemical control solution over time.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the stability studies, the "ground truth" is likely the quantitative measurements of the analytes (e.g., concentration, pH, specific gravity) and qualitative observations (color, clarity) performed using standardized laboratory methods at defined time points. This is analogous to analytical accuracy or reference method values.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
§ 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.