(49 days)
Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
The provided documentation describes the Liquid Assayed Multiqual device, a quality control serum. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or adjudication methods in the way typically expected for a diagnostic or AI-driven device.
This document is a Summary of Safety and Effectiveness (part of a 510(k) submission) for a quality control material. Its primary purpose is to establish substantial equivalence to a predicate device, not to present a detailed performance study with discrete acceptance criteria for a diagnostic tool.
Therefore, many of the requested items cannot be extracted from this document. Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit "acceptance criteria" are stated in the document in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision ranges for analytes). The document focuses on demonstrating that the new device is substantially equivalent to a predicate by having similar intended use, form, matrix, storage conditions, and open vial claims, with the primary difference being the addition of Lactic Acid as an analyte.
The "performance" reported is primarily related to stability:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open Vial Stability | 14 days at 2 to 8°C (LAP Arylamidase stable for 3 days) |
| Thawed and Unopened Stability | 30 days at 2 to 8°C (with exceptions for Total Bilirubin and Alkaline Phosphatase) |
| Shelf Life Stability | 3 Years at -20°C or colder |
Explanation: The "acceptance criteria" here are implied by the stability claims made for the device. The study demonstrating these is referred to generally as "Stability studies."
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "Stability studies" but does not detail the number of samples or batches used for these studies.
- Data Provenance: Not specified. The country of origin for the data or whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a quality control material is its chemical stability and stated analyte values, which are determined through laboratory testing procedures, not expert consensus.
4. Adjudication method for the test set
Not applicable. See point 3.
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 not an AI-driven or diagnostic device that involves human readers or AI assistance.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control device like this would be the analytically determined values and stability characteristics of the biochemical components within the control material, established through validated laboratory methods. It's based on chemical and physical testing rather than clinical outcomes or expert interpretation of images/data.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of the Study:
The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual." These studies resulted in the product claims listed under section 7.0 and 7.1, 7.2, and 7.3. The type of study conducted was a stability study to determine how long the control material retains its specified characteristics under various conditions (open vial, thawed and unopened, and frozen shelf life). All supporting data is stated to be "retained on file at Bio-Rad Laboratories."
Without access to those detailed studies, further specifics on methodology, sample sizes, or exact performance data beyond the claims made cannot be provided from this public summary.
§ 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.