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The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL).

Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. The wells of a microtiterplate are coated with human histone antigen. Antibodies specific for histones present in the patient sample bind to the antigen.

In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.

The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.

This submission is for an in-vitro diagnostic device, not an AI/ML powered device. Hence the provided sections of the 510k summary do not include specific "acceptance criteria" based on performance metrics like sensitivity, specificity, or AUC, nor do they detail a study designed to "prove" the device meets such criteria in the way one might expect for an AI/ML algorithm.

Instead, the submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (INOVA QUANTA Lite™ Histone IgG). The "acceptance criteria" are implied by the demonstration of comparable performance and alignment with the predicate device regarding its intended use for aiding in the diagnosis of SLE or DIL.

Here's an interpretation based on the provided text, framed to address your requested points where applicable, and noting where information is not available due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in-vitro diagnostic (assay) device, the "acceptance criteria" are not explicitly stated as numerical performance targets (e.g., "sensitivity must be >90%"). Instead, they are interpreted as demonstrating comparable performance to the predicate device and expected results from medical literature. The "reported device performance" is qualitative and refers to the overall comparability.

• Results from a comparison study analyzing positive, equivocal, and negative sera.
• Results obtained for externally defined Calibrators.
• Results obtained for samples from apparently healthy subjects (normal population).
  The data show that the assay performs as expected from the medical literature. |
  | Accordance with Medical Literature: Performance should align with established medical understanding of histone antibodies in SLE/DIL diagnosis. | The data show that the assay performs as expected from the medical literature. |
  | Intended Use Fulfilled: Designed for semiquantitative and qualitative determination of IgG and IgM antibodies to histone. | The device is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. It detects Anti-Histone IgG and IgM antibodies. |
  | Methodological Comparability: Indirect noncompetitive enzyme immunoassay, similar sample dilutions, comparable antigens, and detection systems. | Both assays are indirect noncompetitive enzyme immunoassays for the semiquantitative determination of antibodies against Histone in serum. Both recommend the same sample dilutions and use comparable antigens and detection systems. (Note: Varelisa detects IgG and IgM, predicate detects only IgG). |

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

• Sample Size: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera" and "samples from apparently healthy subjects (normal population)," but no specific numbers are given for these cohorts.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).

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

• This information is not applicable and hence not provided for an in-vitro diagnostic assay comparison study. "Ground truth" for these types of tests typically refers to well-characterized patient samples with known clinical diagnoses or reference method results, rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable and not provided for this type of device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This is an assay kit; its performance is its standalone performance when used in a laboratory setting. There isn't an "algorithm" in the typical sense of AI/ML. The "device performance" described in point 1 serves as its standalone performance.

7. Type of Ground Truth Used

• The "ground truth" implicitly used for this type of comparison would be clinical diagnosis (e.g., patients diagnosed with SLE/DIL vs. healthy controls) and/or reference laboratory methods/externally defined calibrators for the detection of histone antibodies, against which the assay results are correlated. The text mentions "positive, equivocal and negative sera" and "samples from apparently healthy subjects (normal population)," implying clinically characterized samples.

8. Sample Size for the Training Set

• Not applicable. This is an immunoassay kit whose reagents and protocol are developed based on scientific principles of antigen-antibody binding, not through a "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

• Not applicable for the reasons mentioned in point 8.

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