(218 days)
EliA™ RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ RNP70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.
EliA™ Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA™ Sci-70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.
EliATM Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-1 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratory and clinical findings. EliATM Jo-1 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.
The new devices belong 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-Methylumbellifery|-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may 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 the EliA™ RNP70, EliA™ Scl-70, and EliA™ Jo-1 immunoassays, which are intended for the semi-quantitative measurement of IgG antibodies to RNP70, Scl-70, and Jo-1 respectively, as an aid in diagnosing specific autoimmune diseases. The information provided is for their 510(k) premarket notification and focuses on establishing substantial equivalence to previously marketed predicate devices.
Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) or the reported device performance against such criteria in a table format.
Instead, the submission states that "the comparability of predicate device and new device is supported by a data set including: results obtained within a comparison study between new and predicate device, results obtained for clinically defined sera, results obtained for samples from apparently healthy subjects (normal population)." It concludes: "In summary, all available data support that the new devices are substantially equivalent to the predicate devices."
This implies a qualitative acceptance criterion of substantial equivalence to the predicate devices (Varelisa U1RNP Antibodies K993589, Varelisa Scl-70 Antibodies K944172, Varelisa Jo-1 Antibodies K944173). The "study that proves the device meets the acceptance criteria" is broadly described as a "comparison study between new and predicate device," along with testing on "clinically defined sera" and "samples from apparently healthy subjects." However, specific quantitative results from these studies were not detailed in the provided summary.
Detailed Information as Requested:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion (Implicit) Reported Device Performance (Summary) Substantial equivalence to predicate devices (Varelisa U1RNP Antibodies K993589, Varelisa Scl-70 Antibodies K944172, Varelisa Jo-1 Antibodies K944173) "All available data support that the new devices are substantially equivalent to the predicate devices." (Quantitative results are not provided in this summary) -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided summary. The text mentions "a data set including results obtained within a comparison study," "clinically defined sera," and "samples from apparently healthy subjects."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be for regulatory submission, but it's not indicated if they were prospective or retrospective. Given they involve "clinically defined sera" and "normal population" samples, these would likely be retrospective selections or collections for a specific validation study.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified. The ground truth for "clinically defined sera" would presumably be based on established clinical diagnoses, likely determined by medical specialists, but the number and qualifications of experts involved in this determination are not mentioned.
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Adjudication Method for the Test Set:
- Not specified. This information is typically relevant for studies where multiple readers or assessors establish ground truth.
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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:
- Not applicable. This device is an in vitro diagnostic (IVD) immunoassay, not an AI software intended for human reader assistance with image interpretation or complex decision-making. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is an automated immunoassay system (EliA IgG method on ImmunoCAP® 100/250 instruments) that performs measurements and provides semi-quantitative results. This is inherently a "standalone" or "algorithm only" performance, as it measures antibody levels in patient samples without direct human interpretation of the assay's output during the measurement process. The results are then used by clinicians as an "aid in clinical diagnosis."
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Likely clinical diagnosis based on a combination of clinical findings and possibly other laboratory tests, given the mention of "clinically defined sera" for conditions like mixed connective tissue disease (MCTD), systemic lupus erythematosus (SLE), scleroderma, and polymyositis/dermatomyositis. For the "normal population" samples, the ground truth would be the absence of these diseases.
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The Sample Size for the Training Set:
- Not specified. The document does not provide details about a training set, which is more common for machine learning or AI-based devices. For an immunoassay, method development and optimization would occur, but it's not typically categorized as a "training set" in the same way as AI.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as a distinct "training set" with ground truth establishment for an AI/ML algorithm is not described for this immunoassay device. Quality control and assay calibration are established using standardized materials and calibrators, as mentioned (e.g., "WHO-standardized IgG Calibrators derived from human serum").
§ 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).