Search Results
Found 1 results
510(k) Data Aggregation
(280 days)
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
EliA™ Gliadinºº IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA™ Gliadin47 IgG uses the EliA IgG method on the instruments Phadia® 100 and Phadia® 250.
EliA™ Gliadinºº IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA™ Gliadinºº IgA uses the EliA IgA method on the instruments Phadia® 100 and Phadia® 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 Phadia 100 and Phadia 250.
The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.
The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.
The total IgG and IgA calibration is based on a set of six WHO-standardized IgG and IgA Calibrators, respectively, 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.
Acceptance Criteria and Device Performance Study for EliA™ Gliadin IgG/IgA Immunoassays
This document summarizes the acceptance criteria and the supporting study for the EliA™ Gliadin IgG and EliA™ Gliadin IgA immunoassays, as presented in the 510(k) summary. These devices are intended for the in vitro semi-quantitative measurement of IgG and IgA antibodies directed to gliadin, respectively, to aid in the diagnosis of celiac disease.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state numerical acceptance criteria for a "study" in the traditional sense of a comparative effectiveness study with defined performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices through various comparability studies. The "reported device performance" is thus presented as evidence of this equivalence.
The primary method for demonstrating equivalence was through 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)." These studies are summarized below as demonstrating laboratory equivalence.
| Performance Metric/Study Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Laboratory Equivalence | Data supporting substantial equivalence to predicate devices (INOVA Quanta Lite Gliadin IgA II, K052143; INOVA Quanta Lite Gliadin IgG II, K052142) across various sample types. | "all available data support that the new devices are substantially equivalent to the predicate devices." This was demonstrated through: |
- Comparison study between new and predicate device
- Results obtained for clinically defined sera
- Results obtained for samples from apparently healthy subjects (normal population) |
Note: The 510(k) summary does not provide specific numerical performance metrics (e.g., correlation coefficients, concordance rates, sensitivity, specificity, etc.) from these equivalence studies, nor does it define explicit numerical acceptance thresholds for these metrics. The conclusion of substantial equivalence is a qualitative statement based on the totality of the collected data.
2. Sample Size and Data Provenance for the Test Set
The document states that comparability was supported by a "data set" that included results from:
- A comparison study between the new devices and predicate devices.
- Clinically defined sera.
- Samples from apparently healthy subjects.
However, the exact sample sizes for these "test sets" (i.e., the number of patient samples used in the comparison studies) are not specified in the provided 510(k) summary.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer is Phadia AB from Uppsala, Sweden, and the US contact is in Michigan, USA, and the predicate devices are INOVA products, it's plausible the data could have originated from various locations, but this is not confirmed.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of "experts" in the context of establishing ground truth for a test set. The ground truth for the "clinically defined sera" would implicitly refer to the clinical diagnosis of celiac disease, which would have been established by medical professionals. However, the exact number or qualifications of these professionals are not specified.
4. Adjudication Method
No adjudication method is mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The studies described focus on the analytical performance and clinical comparability of the device itself, rather than assessing improvements in human reader performance with or without AI assistance. The device is an immunoassay, not an AI-assisted diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance Study
The EliA™ Gliadin IgG and IgA immunoassays are standalone diagnostic devices. Their performance is evaluated directly through the semi-quantitative measurement of antibodies. The "comparison study between new and predicate device" and evaluation with "clinically defined sera" effectively represent standalone performance evaluations to demonstrate analytical and clinical performance in comparison to existing methods.
7. Type of Ground Truth Used
The ground truth used for the evaluation involved:
- Clinical Diagnoses: The document refers to "clinically defined sera," implying that patient samples with confirmed celiac disease diagnoses (or confirmed healthy status) were used. These diagnoses are typically established through a combination of clinical findings, serology, and biopsy results (pathology). The specific method for clinical diagnosis is not detailed.
- Comparison to Predicate Devices: Performance was also assessed by comparing results directly to cleared predicate devices, which serve as a de-facto standard.
8. Sample Size for the Training Set
The document does not describe a separate "training set" in the context of machine learning. These are immunoassay devices, not AI/ML algorithms that typically require large training datasets. The "calibration" of the immunoassay system relies on WHO-standardized calibrators and control materials, which are distinct from a machine learning training set of patient samples.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense, this question is not applicable. The device's calibration curves are established using WHO-standardized IgG and IgA calibrators, derived from human serum.
Ask a specific question about this device
Page 1 of 1