(99 days)
EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CCP in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250.
EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP 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 may be used for up to one month on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to be measured in defined ranges to check whether 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 is a 510(k) summary for the EliA™ CCP and EliA™ CCP Control devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the sense of clinical performance metrics like sensitivity, specificity, etc., against a defined ground truth.
However, based on the provided text, we can extract information relating to the "study" conducted for equivalence.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, Axis-Shield Diastat Anti-CCP (510(k) number: K023285). The reported "performance" relates to the comparability study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (Axis-Shield Diastat Anti-CCP) across various sample types. | Data supports that the new device is substantially equivalent to the predicate device through:Comparison study results between new and predicate deviceResults for clinically defined seraResults for samples from apparently healthy subjects (normal population) |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "a data set" for comparability but does not provide specific numbers for the comparison study, clinically defined sera, or apparently healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinically defined sera" and "samples from apparently healthy subjects," which implies human samples, but details are missing. It is likely retrospective, as it involves comparing the new device's results with an existing predicate, and "clinically defined sera" suggest samples with known diagnoses.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This type of device (an in-vitro diagnostic for antibodies) primarily relies on the predicate device's established performance as the benchmark for "ground truth" in an equivalence study, rather than expert consensus on images or clinical assessments for the test set itself. The "clinically defined sera" would have their ground truth established by established clinical diagnostic criteria for rheumatoid arthritis (RA).
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Adjudication method for the test set: Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically for subjective assessments (e.g., image interpretation). For an immunoassay, the readouts are quantitative or semi-quantitative and are directly compared.
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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 is an immunoassay device, not an AI-powered diagnostic that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself, EliA™ CCP, is a standalone in-vitro diagnostic immunoassay system. It performs its measurement and provides results without human interpretive assistance in the direct measurement process, though human interpretation of the results in conjunction with clinical findings is required for diagnosis. The study described is a standalone performance comparison.
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The type of ground truth used:
- For the comparability study against the predicate device, the "ground truth" for the new device's performance is essentially the results obtained from the predicate device.
- For the clinically defined sera, the ground truth would be the established clinical diagnosis of rheumatoid arthritis (RA) or healthy status, likely based on a combination of clinical findings, established diagnostic criteria (e.g., ACR/EULAR criteria for RA), and other laboratory tests.
- For samples from apparently healthy subjects, the ground truth is their healthy status.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. It's a biochemical assay.
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How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this type of device.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).