(305 days)
EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein 1 IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.
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 Phadia 100 and Phadia 250.
The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.
The total IgA calibration is based on a set of six WHO-standardized IgA 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-specific, method-specific and general reagents that are packaged as separate units.
Here's a breakdown of the acceptance criteria and study information for the EliA™ ß2-Glycoprotein I IgA Immunoassay, based on the provided 510(k) summary:
The provided 510(k) summary primarily focuses on establishing "substantial equivalence" to a predicate device for this in vitro diagnostic (IVD) immunoassay, rather than presenting a performance study with detailed acceptance criteria in the manner one might see for an AI/software device or a medical imaging device. The "performance" here relates to how well the new device compares to the predicate and its ability to detect the target antibodies.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance (Summary) |
|---|---|---|
| Substantial Equivalence | Comparability to predicate device (Varelisa ß2-Glycoprotein I IgA Antibodies, K040450) | Supported by data from: |
- Comparison study between new and predicate device
- Results from clinically defined sera
- Results from samples of apparently healthy subjects (normal population)
Overall Finding: All available data support the new device is substantially equivalent to the predicate device. |
| Intended Use | Semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I to aid in diagnosis of antiphospholipid syndrome (APS) and thrombotic disorders related to systemic lupus erythematosus (SLE). | The device's performance supports its intended use as described. |
| Method | Uses EliA IgA method on Phadia 100 and Phadia 250 instruments. | The device is designed to operate with these instruments and methods. |
| Calibration | IgA calibration based on six WHO-standardized IgA Calibrators; initial calibration curve valid for up to 28 days; includes calibrator (curve) controls with defined recovery ranges. | The system incorporates this calibration method to ensure validity and accuracy. |
Explanation of "Acceptance Criteria" for IVDs in a 510(k) context: For an in vitro diagnostic device seeking 510(k) clearance, acceptance criteria often revolve around demonstrating analytical and clinical performance comparable to a legally marketed predicate device. This typically involves studies on precision, accuracy (comparison to a reference method or predicate), linearity, detection limits, interference, and agreement studies for clinical samples. The provided summary is very high-level and only states that data supports equivalence, rather than detailing specific numerical criteria used in those studies (e.g., "agreement rate >90%").
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide specific sample sizes for the "test set" or explicit data provenance (e.g., country of origin). It generally refers to:
- "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)"
This indicates the data was collected retrospectively from various sample sources to facilitate comparison. Without more detail, it's not possible to determine if the samples were prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For an IVD, "ground truth" (or clinical truth) for samples used in method comparison or clinical concordance studies would typically be established by combining patient clinical diagnoses (e.g., diagnosed with APS or SLE by a rheumatologist/hematologist) with results from established, often predicate, diagnostic tests. The summary implies "clinically defined sera" were used, meaning these samples had a known clinical status, but the process of establishing that status (e.g., number and qualifications of clinicians) is not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the summary. For IVDs, adjudication isn't typically used in the same way as for imaging devices where multiple readers interpret images. Instead, the "ground truth" for clinical samples is based on a patient's overall clinical presentation and diagnosis, typically accepted as definitive for the study.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging AI devices where human readers interpret images. The EliA™ ß2-Glycoprotein I IgA Immunoassay is an in vitro diagnostic (IVD) serological test, not an imaging device, and does not involve human "readers" interpreting results in a way that an MRMC study would be applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the immunoassay system itself. The device is described as a "fully integrated and automated system for immunodiagnostic testing" and requires operation on the "Phadia 100/Phadia 250" instruments which include "software for evaluation of test results." Therefore, its performance is inherently "standalone" in the sense that the instrument-software system processes the sample and yields a result without direct human interpretation of a raw signal. The comparison studies described are essentially evaluating this standalone performance against the predicate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The summary implies two types of "ground truth" for the performance studies:
- Predicate Device Results: For the "comparison study between new and predicate device," the predicate device's results (Varelisa ß2-Glycoprotein I IgA Antibodies, K040450) would serve as a comparative ground truth.
- Clinical Diagnoses: For "clinically defined sera," the ground truth would be the clinical diagnosis of the patient (e.g., presence or absence of APS or SLE-related thrombotic disorders), presumably based on a combination of clinical symptoms, other laboratory findings, and expert physician assessment. The "samples from apparently healthy subjects" provide a "negative" ground truth based on their healthy status.
8. The Sample Size for the Training Set
The summary does not mention a training set in the context of machine learning or AI. This device is an immunoassay, not an AI or machine learning device that requires a separate training phase. The "calibration" of the device is based on a set of WHO-standardized IgA Calibrators, which is distinct from a machine learning training set.
9. How the Ground Truth for the Training Set was Established
As no training set (in the machine learning sense) is discussed, this question is not applicable. The "ground truth" for the calibration is established by using "WHO-standardized IgA Calibrators derived from human serum," implying these calibrators have a known and certified IgA concentration.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).