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Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only.

The Audit® MicroCV™ T-Uptake Calibration/Verification is a human and bovine albumin based, liquid set of QC material. Each level of the set contains T-Uptake analyte. It is used to confirm the proper calibration, linear operating range, and reportable range of T-Uptake. Level A is near the lower limit level and Level E has concentrations near the upper limit of P-Modular analyzer. Levels B, C, and D are prepared in a manner such that an equal distance exists between each consecutive level.

The provided document describes the Aalto Scientific, Ltd. Audit® MicroCV™ T-Uptake Calibration/Verification Set, a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer.

However, the document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a detailed study proving the device meets those criteria.

Here's an analysis of the provided information concerning acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria for the "Audit® MicroCV™ T-Uptake Calibration/Verification Set" itself in terms of performance metrics like accuracy, precision, or detection limits. Instead, it focuses on the equivalence of its characteristics to a predicate device and stability claims.

The closest we get to "performance" are the stability claims.

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

The document mentions "Stability studies have been performed" but does not specify the sample size used for these studies. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to this type of device and study. The device is a quality control material, and its performance is assessed through analytical stability, not through expert-reviewed ground truth on patient samples.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of expert review or adjudication in the context of this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human readers evaluate cases with and without AI assistance. This device is a quality control material, not an interpretive diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. The device itself is a physical quality control material, not an algorithm. Its performance is related to its stability and ability to verify calibration, not an algorithm's output.

7. The Type of Ground Truth Used:

For the stability studies, the "ground truth" would be the expected concentration values of T-Uptake in the quality control material at different time points, as determined by a reference method or validated assay. The document implies that measurement against these established values forms the basis of the stability assessment.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a quality control material, not a machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set.

Summary of the Study and "Acceptance" for K112143:

The document primarily focuses on demonstrating substantial equivalence to the predicate device, Audit® MicroCV™ Immunoassay Linearity Set (K062668), based on comparable technical characteristics and intended use.

The study that supports the device's claims is stability testing, which aimed to determine the shelf life and open-bottle stability of the Audit® MicroCV™ T-Uptake Calibration/Verification Set.

• Study Design: Implied to be real-time stability studies.
• "Acceptance Criteria" for Stability: The primary "acceptance criteria" presented are the defined stability periods:
  • Open Bottle: 10 days at 2 - 8° C.
  • Shelf Life: Two Years (unopened) at 2 - 8° C.
• "Study Results" (Reported Performance): The document states that "All supporting data is retained on file at Aalto Scientific, Ltd." and explicitly claims the "Product claims are as follows" with the listed stability periods. This indicates that the conducted stability studies demonstrated performance meeting these stated claims.
• Data Detail: The submission states that supporting data for stability is "retained on file." No specific raw data, statistical analysis, or detailed breakdown of the stability study's methodology (e.g., number of batches tested, frequency of testing, acceptance criteria for allowable drift) is provided in this summary.

In essence, the "study" is the internal stability testing, and the "acceptance criteria" are the target stability durations. The declared performance indicates these criteria were met, leading to the substantial equivalence determination by the FDA.

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