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For in vitro quantitative determination Apolipoprotein A-1 in serum and plasma.

Apolipoprotein A-1 measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein A-1 in serum and plasma for use on the INTEGRA family of analyzers.

This 510(k) summary describes a device that is substantially equivalent to a previously marketed device, rather than providing independent acceptance criteria and a study proving the device meets those criteria. The submission focuses on demonstrating the similarities between the modified device and its predicate, implying that if the predicate device met acceptance criteria, the modified device, being similar, also meets them.

Therefore, many of the requested sections (acceptance criteria, device performance values, sample sizes, expert qualifications, adjudication, MRMC studies, standalone studies, ground truth types for test and training sets) cannot be directly extracted as they are not explicitly stated for the modified device in this document. The document argues for substantial equivalence primarily on the basis of identical intended use, indications for use, methodology, instrument, measuring range, and formulation.

However, I can extract the information provided regarding the similarities and the study supporting the substantial equivalence claim.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission, K990594, focuses on demonstrating substantial equivalence to a previously marketed predicate device (Roche INTEGRA Reagent Cassette for Apolipoprotein A-1, K954992) rather than establishing new, specific acceptance criteria for the modified device and then conducting a study to prove it meets them. The "study" here is a comparison demonstrating that the modified device is fundamentally the same as its predicate in key performance and design aspects.

The key argument is that because the predicate device was already deemed safe and effective, and the modified device is substantially equivalent to the predicate, the modified device also meets the necessary safety and effectiveness requirements.

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a substantial equivalence submission, it does not define new acceptance criteria for the modified device, nor does it provide a new performance study with specific performance values against new acceptance criteria. Instead, it highlights the similarities between the modified device and its predicate, implying that the predicate's established performance serves as the benchmark.

Note: The "reported device performance" here is the design and functional specification of the modified device, which is presented as identical to the predicate device. Specific numerical performance data (e.g., accuracy, precision, linearity) for the modified device itself are stated as being "incorporated into the draft labeling in Section V of this submission," but are not provided in this 510(k) summary itself. The core of the argument is that since these features are identical, the performance will be equivalent.

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

The document does not explicitly state the sample size used for a "test set" for the modified device, nor its data provenance. The summary focuses on showing design and functional equivalence to the predicate. The "specific data on the performance of the test" is mentioned as being in Section V of the submission, but not summarized here.

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

Not applicable for this type of substantial equivalence submission. There is no mention of experts establishing a ground truth for a test set in this document.

4. Adjudication Method for the Test Set

Not applicable for this type of substantial equivalence submission.

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

No. This is an in vitro diagnostic reagent, not an imaging or interpretation device that would typically involve human readers or MRMC studies.

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

While the device is an "algorithm only" in the sense of being an automated chemical assay, the document does not present a standalone performance study with specific metrics for the modified device in this summary. Instead, it relies on the predicate's established performance to argue for substantial equivalence. The summary states that "Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission." This would likely contain data on precision, accuracy, linearity, etc., similar to a standalone study for the modified device, but these details are not provided in the 510(k) summary itself.

7. The Type of Ground Truth Used

Not applicable in the context of this summary. For an immunoturbidimetric assay, "ground truth" would typically refer to a reference method or a highly accurate comparative method used during validation studies (presumably for the predicate device and the modified device's internal validation), but this is not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that utilizes training sets in the conventional sense.

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

Not applicable.

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