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Liquichek Spinal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Liquichek Spinal Fluid Control is a human based control with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

Each human donor unit used to manufacture this control was tested by FDA accepted methods and found to be non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Liquichek Spinal Fluid Control:

Acceptance Criteria and Device Performance

Note: The document explicitly states that "Stability studies have been performed and acceptance criteria were met for Liquichek Spinal Fluid Control to determine the stability claims." This implies the reported device performance is the acceptance criteria that was met. The specific quantitative acceptance criteria (e.g., within X% of initial value, acceptable range of CV) are not detailed in this summary document.

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size for Test Set: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" when describing how mean values and ±3SD ranges were derived for value assignment. For stability studies, the document only states "Stability studies have been performed," without specifying the number of samples or runs.
   • Data Provenance: The document does not specify the country of origin for the data. The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. The data is retrospective in the sense that the studies were completed before the 510(k) submission, but the design of new stability studies would typically involve prospective testing over time for the specific product lot.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation of results or establishment of a "ground truth" in the clinical sense. The "ground truth" for a control material is typically its assigned value and expected stability, determined through rigorous analytical testing rather than expert clinical consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As a quality control material, clinical adjudication methods are not relevant. The "ground truth" (assigned values, stability) is established through analytical methods.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, i.e., 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. No human reader performance or AI assistance is involved.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a quality control material, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this quality control material is its assigned values and stability characteristics, which are determined through:

   • Replicate analyses: Performed by the manufacturer and/or independent laboratories using manufacturer-supported reagents and a representative sampling of the product lot.
   • Stability studies: Conducted to determine the open vial and shelf life stability claims.

7. The sample size for the training set: Not applicable. This device is a biochemical control, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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