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Liquichek Immunology Control 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.

Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, stabilizers and preservatives. This provided in liquid form for convenience. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found 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 information regarding the Liquichek Immunology Control device, broken down by your requested sections:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For this device, "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The new device must demonstrate performance that is "as good as" or "equivalent" to the predicate, especially regarding stability claims and the ability to control the listed analytes. The provided document highlights the similarities and differences, and the performance characteristics for the new device are presented as meeting the requirements for its intended use, which are aligned with the predicate's purpose.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Real time stability studies were performed to establish Thawed and Thawed and unopened stability claims. Accelerated stability studies were performed for establishing the shelf life." It also mentions that "the mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses... The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents, and a representative sampling of this lot of product."

• Sample Size: The exact sample size (number of control units, number of replicates) for these studies is not explicitly stated in the provided document. It refers generally to "replicate analyses" and "a representative sampling."
• Data Provenance:
  • Country of Origin: Not explicitly stated, though Bio-Rad Laboratories is based in Irvine, California, USA, making it highly probable the data is primarily from the USA or laboratories affiliated with Bio-Rad globally.
  • Retrospective or Prospective: The stability studies are described as "real-time" and "accelerated," which indicates prospective data collection. The value assignment process using "replicate analyses" would also be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of device (quality control material), the concept of "ground truth" established by experts in the context of diagnostic interpretation (e.g., radiologists) is not applicable.

Instead, the "ground truth" for the test set (i.e., the established concentration ranges and stability) is determined through:

• Replicate Analyses: Multiple measurements of various analytes using established, validated methods.
• Manufacturer and Independent Laboratories: Measurements are performed by Bio-Rad Laboratories and/or independent laboratories.
• Unity™ Interlaboratory Program: Data from this program is included in the determination of some ranges, which indicates a wider consensus approach for value assignment based on multiple laboratory results.

There are no "experts" in the sense of clinicians or diagnosticians establishing ground truth for individual cases, as this is a quality control material intended to monitor the precision of laboratory procedures, not diagnose patients. The "experts" are more akin to highly skilled laboratory technicians and statisticians who conduct and analyze the reference measurements. No specific number or qualifications are given beyond "manufacturer and/or independent laboratories."

4. Adjudication Method for the Test Set

Not applicable. As explained above, this isn't a diagnostic device where expert adjudication of cases is performed. The "adjudication" of the control's values and stability is based on meticulous laboratory testing, statistical analysis of replicate measurements, and interlaboratory comparisons (Unity™ program).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret medical images or data. The Liquichek Immunology Control is a quality control material, not a diagnostic tool requiring human interpretation for its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a consumable laboratory reagent, not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI algorithms is not applicable. Its performance is inherent in its chemical and biological stability and the accuracy of its assigned values when measured by laboratory instruments.

7. The Type of Ground Truth Used

The "ground truth" for the Liquichek Immunology Control is primarily:

• Reference Values: Analytes are assigned mean values and corresponding ±3SD ranges based on replicate analyses using manufacturer-supported reagents and methods.
• Stability Data: Determined scientifically through real-time and accelerated stability studies.

This is a form of empirical measurement data derived from robust laboratory procedures, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set." Its values are established through laboratory testing and statistical analysis, not by training an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it. The analogous process for this device is the "Value Assignment" described in section 5.0, where mean values and ±3SD ranges are derived from replicate analyses performed by the manufacturer and/or independent laboratories, often incorporating data from interlaboratory programs.

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