(102 days)
EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA Immunoassav uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.
The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve. which mav be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test, method specific, and general reagents that are packaged as separate units.
This document describes a 510(k) submission for the EliA™ dsDNA Immunoassay and EliA™ ANA Control. The submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria. Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document primarily details the intended use, classification, and comparison to a predicate device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the traditional sense of a clinical trial demonstrating a device meets a pre-defined performance threshold. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through "laboratory equivalence" studies as described below.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "a comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)". However, specific sample sizes for these test sets are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The "ground truth" here would likely refer to the clinical diagnosis of Systemic Lupus Erythematosus (SLE) for "clinically defined sera". However, details on how these diagnoses were established or by whom are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as the document does not describe a process involving adjudication of expert opinions for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable to this type of in vitro diagnostic device (immunoassay). This is an immunoassay measuring anti-dsDNA antibodies, not an imaging device requiring human interpretation, nor does it incorporate AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an immunoassay, and its performance is inherently "standalone" in the sense that it provides a quantitative measurement. There isn't an "algorithm only" component that would be compared to a human-in-the-loop. The device's performance is its output based on the biological sample.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "clinically defined sera," the ground truth implicitly stems from a clinical diagnosis of Systemic Lupus Erythematosus (SLE), as the device aids in this diagnosis. For "samples from apparently healthy subjects," the ground truth is their healthy status. However, the exact methodology for establishing these ground truths (e.g., expert consensus based on specific clinical criteria, detailed clinical outcomes) is not explicitly described.
8. The sample size for the training set
This document describes a medical device, not a machine learning model that requires a distinct "training set." Therefore, a separate training set in the AI/ML context is not applicable. The "calibration" of the device is mentioned, which involves a set of six WHO-standardized IgG Calibrators.
9. How the ground truth for the training set was established
As there is no "training set" in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's calibration involves "WHO-standardized IgG Calibrators derived from human serum," implying these calibrators have established, known concentrations of IgG.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).