Search Results

The a-Gliatest® IgA is intended for the semi-quantitative determination of IgA antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-Gliatest® IgG is intended for the semi-quantitative determination of IgG antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-GliaPep® IgA is intended for the semi-quantitative determination of IgA antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-GliaPep® IgG is intended for the semi-quantitative determination of IgG antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

Each test kit for a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG consists of one (1) microtiter plate (12 strips of 8 microwells coated with purified a-gliadin antigen or deamidated gliadin peptide antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.

The provided document describes the Grifols USA, Inc. a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG devices, which are intended for the semi-quantitative determination of IgA/IgG antibodies directed against gliadin or deamidated gliadin peptide in human serum as an aid in the diagnosis of celiac disease.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through comparison with a predicate device (Aeskulisa® Glia A/G (K052439)) and through performance metrics like precision, linearity, and detection limits. The method comparison and clinical studies aim to demonstrate substantial equivalence and adequate diagnostic performance.

Below is a summary of the reported performance for each device, with implied acceptance criteria based on the context of 'substantial equivalence' to the predicate and satisfactory clinical utility. The document does not explicitly state pre-defined acceptance criteria for the clinical or method comparison studies in terms of specific percentages, but rather presents the results. For analytical performance, the studies demonstrate what is considered acceptable.

2. Sample Size Used for the Test Set and Data Provenance

• α-Gliatest® IgA:
  • Method Comparison Test Set: 178 clinical samples. Provenance: Includes clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective.
  • Clinical Study Test Set: 262 clinical samples (114 celiac positive, 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and/or confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 196 healthy blood donor samples. Retrospective.
• α-Gliatest® IgG:
  • Method Comparison Test Set: 198 clinical samples (51 celiac positive, including 10 IgA-deficient celiac patients; negative samples from healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective.
  • Clinical Study Test Set: 285 clinical samples (127 celiac positive, 10 IgA-deficient celiac patients; 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 196 healthy blood donor samples. Retrospective.
• α-GliaPep® IgA:
  • Method Comparison Test Set: 179 clinical samples. Provenance: Clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective. The samples were within the linearity range of the assay.
  • Clinical Study Test Set: 241 clinical samples (93 celiac positive, 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 145 healthy blood donor samples. Retrospective.
• α-GliaPep® IgG:
  • Method Comparison Test Set: 201 clinical samples (57 celiac positive, including 10 IgA-deficient celiac patients; 146 negative samples recruited similarly to other assays). Provenance: Clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective. The samples were within the linearity range of the assay.
  • Clinical Study Test Set: 253 clinical samples (95 celiac positive, including 10 IgA-deficient celiac patients; 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings (31.6%) and confirmed with biopsy (68.4%). Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 145 healthy blood donor samples. Retrospective.

For all studies, data provenance is global/not specified, and the data is retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth for the test sets. It mentions that celiac positive samples were "clinically-diagnosed celiac positive (clinical history and/or biopsy)" and "diagnosed with clinical findings and confirmed with biopsy." This implies that the ground truth was established by medical professionals, likely gastroenterologists or pathologists, based on established diagnostic criteria for celiac disease, including clinical presentation and histological findings from biopsy. However, the specific number and formal qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in ground truth determination or in the interpretation of clinical findings and biopsies for the test set. The ground truth seems to be implicitly accepted based on the "clinical findings and/or biopsy" diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These devices are in vitro diagnostic (IVD) assays, not imaging interpretation algorithms where human readers would typically be involved in interpreting results. The studies compare the performance of the device itself to a predicate device or to clinical ground truth, not to human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies conducted are standalone performance evaluations of the assay devices. The "method comparison studies" and "clinical studies" evaluate the performance of each assay (α-Gliatest® IgA, α-Gliatest® IgG, α-GliaPep® IgA, α-GliaPep® IgG) in isolation, comparing its output to a predicate device's output or to the clinical ground truth. There is no human-in-the-loop component described for the operation or interpretation of these assays beyond standard laboratory procedures.

7. The Type of Ground Truth Used

The ground truth for celiac positive samples was established based on:

• Clinical findings: Clinical history and presentation consistent with celiac disease.
• Biopsy: Histological confirmation from intestinal biopsy, which is a gold standard for celiac disease diagnosis.

For negative samples, the ground truth was based on:

• Healthy blood donors.
• Patients with other relevant conditions (IBD, IBS, autoimmune disorders, infectious diseases, Type 1 diabetes) who would not be expected to have celiac disease.

This can be categorized as a combination of expert consensus (clinical findings) and pathology (biopsy).

8. The Sample Size for the Training Set

The document primarily describes validation studies (test sets) and does not explicitly mention a separate "training set" for the development of these IVD assays. IVD products are typically developed through iterative processes of antigen/antibody selection and optimization, with assay parameters being refined, but these development phases are not usually referred to as "training sets" in the same way machine learning models are. The calibrators and controls are formulated from pooled sera, and new lots are calibrated against original calibrators, which involves testing (effectively a form of internal "training" or standardization) against:

• Original calibrators
• Normal human sera
• Clinical samples
• Internal standards

However, a specific "training set" size for algorithm development (as would be typical for AI/ML devices) is not applicable or stated for this type of immunoassay.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" for an algorithm in the AI/ML sense is not applicable to these IVD assays. Instead, the assay's operational parameters (like calibrator values) are established using:

• Pooled sera with known anti-gliadin antibody levels from celiac patients.
• Normal human sera.
• Clinical samples.
• Internal standards.

The ground truth for these calibrators and controls would stem from the clinical diagnoses (clinical findings and/or biopsy) of the patient populations from which the sera were obtained. The document states, "Calibrators are dilutions of pooled sera with anti-gliadin antibody from patients with celiac disease." This implies that the ground truth for these pooled sera was established through the diagnosis of celiac disease in the donor patients.

Ask a specific question about this device

The Immunofixation Electrophoresis (IFE) Test using Interlab G 26 v2.0 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.

The Interlab IFE kits 2, 4, and 6 samples per gel, are intended to be used with the automated Interlab G26 v1.0 and v2.0 electrophoresis analyzers in conjunction with the Easy Mask antisera application device.

The Immunofixation Electrophoresis (IFE) Test kit is packaged as a 20 (2 samples/ gel), 40 (4 samples/ gel) or 60 (6 samples/ gel) test kits. The kit contains ready-to-use components: 10 gel plates, 2 buffered sponges, acid violet stain (500 mL), washing solution for applicators (80 mL), washing solution 1 for IFE (80 mL), washing solution 2 for IFE (80 mL), IFE diluent (6 or 12 mL), disposable sample trays 26 (10 pcs) or 39 (10 pcs), blotters A (10 pcs), blotters L (10 pcs), blotters G (10 pcs), and 1 CD Package Insert.

The following components are required for the test but are not supplied in the test kit: destain solution pack (6x100 mL), fixative solution (1.5 mL) and specific antisera Anti-Human-IgG (1 mL), Anti-Human-IgA (1 mL)), Anti-Human-IgM (1 mL), Anti-Human-Kappa (1 mL) and Anti-Human-Lambda (1 mL).

The Automated Interlab G 26 ver. 2 Electrophoresis Analyzer provides automated pipetting of samples from barcode sample tubes in a rack and dilutes the samples into a sample tray for dispensing onto an agarose gel. The protein fraction separation uses the principle of electrophoresis; separation involving electrically charged molecules that orient and migrate at different rates when subjected to an electric field. The migration is performed at a constant temperature, obtained through the use of a Peltier device, on assay specific buffered agarose gel plates. The agarose gel medium provides a support and molecular sieve allowing the different fractions to migrate to points based on individual net charges.

After electrophoresis, the gel is heated to "fix" the focalized proteins, followed by assay specific staining, destaining, washing and drying. All methods utilizing a quantitative assessment are immediately processed using the on-board densitometer. The signal obtained for each specimen result is sent to the personal computer and presented using the Elfolab interpretive software. The Interiab G26 instrument is preprogrammed with all necessary firmware to conduct and manage all phases of the analytical procedures used in Interlab manufactured assays. The instrument works in coniunction with a personal computer using Windows® based software featuring pull down menus and intuitive icons for easy instrument control, selection of analytical methods, and data evaluation.

Instrument design includes: automated application of the samples on the agarose gel; electrophoretic migration; "heat fixing" proteins to the gel; gel staining/ destaining/ drying, densitometric reading of the gel; and data transmission and processing.

The Interlab Easy Mask Antisera Applicator Device is a standalone electronic instrument identical to the peltier contained within the Interlab G26 and is designed to work in conjunction with the Interlab G26. This device allows for accurate and simplified processing of various electrophoretic agarose gel assays that require reagent or antisera overlays. This device allows for easier user processing of the manual steps necessary in antisera type assays (IFE, BJ, Penta) by allowing the user to work unencumbered from mechanical arms and instrument covers.

The Easy Mask provides functions identically to the processing steps used in other agarose gel systems that require the user to perform the manual antisera steps directly on the instrument. Through the use of a Peltier and vacuum pump, the temperature across the surface of the gel remains at a precise and controlled temperature, thus improving assay quality and decreasing time. Instrument is designed to receive the Gel Holder from the Interiab G26 Instrument. The Gel Holder is inserted into a template which places the gel in direct contact with the peliter plate assuring uniform and controlled temperature over the entire surface of the gel. Perfect adhesion of the geltier plate is accomplished using a vacuum pump. Assay specific application masks are placed in the frame, which provide precise application of the antisera or reagents during the incubation phase. After the incubation phase is complete, the frame locks over the gel providing a calibrated heated press to blot away un-bound antisera and reagents. When processing is completed on the Easy Mask, the operator places the Gel Holder back in the parking location on the Interlab G26 for the final steps of the analysis.

Here's a breakdown of the acceptance criteria and the study details for the Immunofixation Electrophoresis Test using Interlab G26 Instrument, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For this particular device, the "acceptance criteria" are implicitly defined by the demonstration of 100% agreement and reproducibility with a previously cleared predicate device. The performance is reported as concordance. There are no explicit numerical thresholds for sensitivity or specificity stated as acceptance criteria, as this is a qualitative test comparing to a predicate.

2. Sample Sizes Used for the Test Set and Data Provenance

• Reproducibility (Within-Run): 2 series of 8 samples (1 normal, 7 pathological with monoclonal bands). For each sample, 6 replicates were run. Total replicates = (2 series * 8 samples/series * 6 replicates/sample) = 96.
• Reproducibility (Between-Run): 4 cycles of 3 agarose gel plates used to analyze 18 samples (3 normal, 15 pathological with monoclonal bands). Total runs/gels = (4 cycles * 3 gels/cycle) = 12 gels.
• Inter-Lot Reproducibility: 9 different samples (1 normal, 8 pathological with monoclonal bands) analyzed using 3 different batches of antisera on 9 agarose gel plates.
• Interference (Serum): Not explicitly stated, but implies a sufficient number of spiked and un-spiked samples.
• Interference (Urine): 8 urine samples (7 pathological, 1 normal).
• Method Comparison (Serum): 102 serum samples (10 normal, 92 suspected pathological).
• Method Comparison (Urine): 64 urine samples (56 pathological, 8 negative).

Data Provenance: The document does not explicitly state the country of origin for the patient samples. The studies seem to be retrospective, using existing samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The ground truth for the test set interpretations (e.g., comparison studies, reproducibility) was established by visual inspection. The document does not specify the number of experts, nor their qualifications (e.g., "radiologist with 10 years of experience"). This type of qualitative visual interpretation is typically done by trained laboratory professionals or experts in immunofixation electrophoresis.

4. Adjudication Method for the Test Set

The document does not detail a formal adjudication method (e.g., 2+1, 3+1). The evaluation was based on visual inspection for agreement and reproducibility. It can be inferred that either a single expert visually inspected and confirmed the results, or multiple experts reviewed, and any discrepancies were resolved, but the process is not explicitly described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focused on the performance of the device itself compared to a predicate device, not on the improvement of human reader performance with or without AI assistance. The device is for qualitative diagnostic separation and identification, interpreted visually.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described are essentially standalone performance evaluations of the Interlab G26 v2.0 instrument. The visual inspection "evaluation" is about the clarity and accuracy of the bands produced by the instrument, which is then interpreted by a human. The "standalone" here refers to the instrument's ability to process samples and produce the electrophoretic patterns correctly, rather than an AI or algorithm making a final diagnosis without human input. The output is a visual pattern that a human then interprets.

7. The Type of Ground Truth Used

The ground truth used for the test set appears to be:

• Visual Inspection/Expert Consensus: For reproducibility, precision, and interference, the "ground truth" for what constitutes a correct pattern (monoclonal bands, normal pattern, etc.) is based on established interpretation criteria for immunofixation electrophoresis and is visually confirmed.
• Predicate Device Agreement: For the method comparison studies, the results obtained from the predicate G26 v1 device (which was previously cleared by the FDA) served as the "reference method" or de-facto ground truth for qualitative agreement.

There is no mention of pathology, long-term outcomes data, or other definitive "gold standard" methods used to establish ground truth.

8. The Sample Size for the Training Set

The document does not specify a training set in the context of machine learning or AI. This device submission is for an automated electrophoresis instrument, not an AI/ML algorithm that requires a training set. The "preprogrammed" firmware and software (Elfolab system) manage the analytical procedures and data evaluation, but it's not described as an adaptive learning system that undergoes a "training" phase with data.

9. How the Ground Truth for the Training Set was Established

As no training set (in the AI/ML sense) is described, there's no information on how its ground truth was established.

Ask a specific question about this device