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510(k) Data Aggregation
(574 days)
MVM
The Aptiva Celiac Disease IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-tissue transglutaminase IgG autoantibodies and anti-deamidated gliadin peptide IgG autoantibodies in human serum. The presence of these antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis, particularly in patients with selective IgA deficiency.
The Aptiva Celiac Disease IgG Reagent is intended for use with the Inova Diagnostics Aptiva System.
The Aptiva Celiac Disease IgG reagent utilizes particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (tissue transglutaminase [tTG] and deamidated gliadin peptide [DGP]) in the Aptiva Celiac Disease IgG reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgG capture antibody (IgG Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.
The Aptiva instrument is a fully automated, random access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.
The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that preserve the proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using buffer located within the cartridge.
A patient's serum is diluted 1:23 with Aptiva system rinse by the instrument in a disposable cuvette. A small amount of the diluted sample is combined with assay buffer and the microparticle suspension in a second cuvette, and mixed (final serum dilution: 1:230). This reaction cuvette is incubated for 9 ½ minutes at 37°C. The cuvette is then exposed to a small magnet that holds the microparticles in place. The liquid is aspirated, and the microparticles are resuspended as system rinse is added to the cuvette and the magnet is removed. This wash cycle is repeated one more time. During the third wash, no system rinse is added after the aspiration step. After the third wash, phycoerythrin conjugated polyclonal anti-human lgG (known as PE Tracer IgG) is added to the microparticles in the cuvette, and mixed. Again, the cuvette is incubated for 9 ½ minutes at 37℃. Three wash steps, as described above, are performed on the microparticles. Following the wash steps, the microparticles are transferred to the of the instrument, where a charge coupled device (CCD) camera takes multiple images in order to identify and count the three unique microparticle regions, as well as determine the amount of conjugate on the microparticles. The control microparticle, a third particle, coated with goat anti-human IgG, is included in the reagent in as a control to flag low concentrations of IgG the patient serum sample as an assay verification step. The median fluorescent intensity (MFI) is proportional to the amount of PE Tracer that is bound to the human IgG, which is proportional to the amount of IgG antibodies bound to the corresponding microparticle regions.
For quantitation, the DGP IgG and tTG IgG assays (together as part of the Aptiva Celiac Disease IgG Reagent) each utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge RFID tag. Every new lot of reagent cartridge must be calibrated before first use with the reagent specific calibrators. Based on the results obtained with the calibrators included in the Aptiva Celiac Disease IgG Calibrator kit (sold separately), an instrument specific Working Curve is created for each assay, which is used to calculate reported fluorescent light units (FLU) from the median fluorescent intensity (MFI) instrument signal obtained for each sample, on each of the two assays within the reagent.
Aptiva Celiac Disease IgG Calibrators and Aptiva Celiac Disease IgG Controls are sold separately.
The Aptiva Celiac Disease IgG Reagent kit contains the following materials:
One (1) Aptiva Celiac Disease IgG Reagent Cartridge, containing the following reagents for 200 determinations:
- a. Aptiva Celiac Disease IgG microparticle containing 3 unique microparticle regions coated with recombinant tissue transglutaminase, deamidated gliadin peptide, or goat antihuman IgG antibody.
- b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
- C. PE Tracer IgG - phycoerythrin (PE) labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
- ð. Rehydration Buffer - containing protein stabilizers and preservatives.
This document describes the analytical and clinical performance of the Aptiva Celiac Disease IgG Reagent, an immunoassay for the semi-quantitative determination of anti-tissue transglutaminase IgG autoantibodies (tTG IgG) and anti-deamidated gliadin peptide IgG autoantibodies (DGP IgG) in human serum. This device is intended as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The document presents several analytical performance characteristics and their corresponding acceptance criteria, along with the reported performance values. The primary clinical acceptance criteria are related to sensitivity and specificity, and the agreement with a predicate device.
| Test Category | Acceptance Criteria | Reported Device Performance (DGP IgG) | Reported Device Performance (tTG IgG) |
|---|---|---|---|
| Precision | Total %CV: |
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(541 days)
MVM
The Aptiva Celiac Disease IgA Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-tissue transglutaminase IgA autoantibodies and anti-deamidated gliadin peptide IgA autoantibodies in human serum. The presence of these autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis. The Aptiva Celiac Disease IgA Reagent is intended for use with the Inova Diagnostics Aptiva System.
The Aptiva Celiac Disease IgA reagent utilizes particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (tissue transglutaminase [tTG] and deamidated gliadin peptide [DGP]) in the Aptiva Celiac Disease IgA reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgA capture antibody (IgA Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.
The Aptiva instrument is a fully automated, random access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.
The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that preserve the proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using buffer located within the cartridge.
A patient's serum is diluted 1:46 with Aptiva system rinse by the instrument in a disposable cuvette. A small amount of the diluted sample is combined with assay buffer and the microparticle suspension in a second cuvette, and mixed (final serum dilution: 1:230). This reaction cuvette is incubated for 9 ½ minutes at 37°C. The cuvette is then exposed to a small magnet that holds the microparticles in place. The liquid is aspirated, and the microparticles are resuspended as system rinse is added to the cuvette and the magnet is removed. This wash cycle is repeated one more time. During the third wash, no system rinse is added after the aspiration step. After the third wash, phycoerythrin conjugated polyclonal anti-human IgA (known as PE Tracer IgA) is added to the microparticles in the cuvette, and mixed. Again, the cuvette is incubated for 9 ½ minutes at 37℃. Three wash steps, as described above, are performed on the microparticles. Following the wash steps, the microparticles are transferred to the of the instrument, where a charge coupled device (CCD) camera takes multiple images in order to identify and count the three unique microparticle regions, as well as determine the amount of conjugate on the microparticles. A third particle, coated with goat antibodies, is present in the reagent as a control to flag low concentrations of IgA in the sample as an assay verification step. The median fluorescent intensity (MFI) is proportional to the amount of PE Tracer that is bound to the human IgA, which is proportional to the amount of IgA antibodies bound to the corresponding microparticle regions.
For quantitation, the DGP IgA and tTG IgA assays (together as part of the Aptiva Celiac Disease IgA Reagent) each utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge RFID tag. Every new lot of reagent cartridge must be calibrated before first use with the reagent specific calibrators. Based on the results obtained with the calibrators included in the Aptiva Celiac Disease IgA Calibrator kit (sold separately), an instrument specific Working Curve is created for each assay, which is used to calculate reported fluorescent light units (FLU) from the median fluorescent intensity (MFI) instrument signal obtained for each sample, on each of the two assays within the reagent.
Aptiva Celiac Disease IgA Calibrators and Aptiva Celiac Disease IgA Controls are sold separately.
The Aptiva Celiac Disease IgA Reagent kit contains the following materials:
One (1) Aptiva Celiac Disease IgA Reagent Cartridge, containing the following reagents for 250 determinations:
- a. Aptiva Celiac IgA microparticle containing 3 unique microparticle regions coated with recombinant tissue transglutaminase, deamidated gliadin peptide, or goat anti-human IgA antibody.
- b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
- PE Tracer IgA phycoerythrin (PE) labeled anti-human IgA antibody, containing buffer, C. protein stabilizers and preservative.
- d. Rehydration Buffer - containing protein stabilizers and preservatives.
The provided text is a 510(k) Summary for the Aptiva Celiac Disease IgA Reagent, an in vitro diagnostic device. It describes the analytical and clinical performance of the device to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or the establishment of ground truth by expert consensus. Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device studies.
However, I can extract the acceptance criteria and reported performance for analytical aspects of this specific in vitro diagnostic device, as well as details regarding sample size, data provenance, and the type of ground truth used for performance evaluation.
Acceptance Criteria and Reported Device Performance
The device under review is an in vitro diagnostic (IVD) test, not an AI/ML-based medical imaging device. As such, the acceptance criteria and performance evaluation are based on typical analytical validation parameters for immunological assays, such as precision, limit of detection, linearity, interference, and clinical sensitivity/specificity against established reference methods or patient diagnoses.
Table of Acceptance Criteria and Reported Device Performance:
| Study/Parameter | Acceptance Criteria (Set by Manufacturer) | Reported Device Performance (as presented) |
|---|---|---|
| Precision | Total %CV: |
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(232 days)
MVM
EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTA-plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA GliadinDP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgA uses the EliA IgA method on the instrument Phadia 2500/5000.
EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells (EliA Celikey IgG Wells, EliA GliadinDP IgA Wells, EliA GliadinDP IgG Wells), EliA Sample Diluent, EliA IgG reagents (EliA IgG Conjugate, EliA IgG Calibrator Strips, EliA IgG Curve Control Strips, EliA IgG Calibrator Well), and EliA IgA reagents (EliA IgA Conjugate, EliA IgA Calibrator Strips, EliA IgA Curve Control Strips, EliA IgA Calibrator Well). The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA Celikey IgG and EliA GliadinDP IgA and EliA GliadinDP IgG tests.
The provided document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence determination for the Phadia AB EliA Immunoassays (Celikey IgG, GliadinDP IgA, GliadinDP IgG) for use on the Phadia 2500/5000 instrument. The document primarily focuses on demonstrating that the performance of these assays on the new instrument platform is substantially equivalent to their performance on a previously cleared instrument (Phadia 250).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a single table outlining "acceptance criteria" alongside "reported device performance" for the overall substantial equivalence determination. Instead, it details performance characteristics for various analytical aspects, and the acceptance criteria are implied by the ranges and thresholds specified for these studies. The primary "acceptance criteria" for the overall submission appear to be demonstrating equivalence to the predicate device and meeting specific statistical thresholds for precision and linearity.
However, based on the sections "M. Performance Characteristics (if/when applicable)" and "2. Comparison studies: - Instrument comparison C.", we can construct a table for the analytical performance and comparative study results:
Table: Acceptance Criteria (Implied) and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied from stated goals or predicate performance) | Reported Device Performance (Phadia 2500/5000) |
|---|---|---|
| Precision | Variability assessed across 21 runs (3 instruments x 7 runs) for each assay. (No explicit %CV targets given, but comparison to typical acceptable analytical variation in such assays is implied). CLSI EP05-A3 guidelines followed. | EliA Celikey IgG: Total Imprecision (%CV): 27.9% (at 1.6 EliA U/mL), 5.9% (at 7.6), 6.6% (at 9.6), 5.1% (at 104.4), 5.3% (at 274.6). |
| EliA GliadinDP IgA: Total Imprecision (%CV): 18.2% (at 0.8), 3.6% (at 7.4), 4.5% (at 8.7), 5.0% (at 42.8), 9.3% (at 135.3). | ||
| EliA GliadinDP IgG: Total Imprecision (%CV): 13.0% (at 3.6), 7.0% (at 7.2), 5.9% (at 9.3), 8.1% (at 73.7), 7.7% (at 219.6). | ||
| Linearity/Reportable Range | Assays should demonstrate linearity across their measurement range. CLSI EP06-A guidelines followed. "Slope for the regression lines should be 0.9 - 1.1... and intercept close to 0." | EliA Celikey IgG: Slope: 1.01-1.04, Intercept: 0.49-2.48, R2: 0.99-1.00. |
| EliA GliadinDP IgA: Slope: 0.99-1.00, Intercept: -1.69-0.79, R2: 1.00. | ||
| EliA GliadinDP IgG: Slope: 0.98-1.00, Intercept: -5.65-1.02, R2: 0.99-1.00. | ||
| All R2 values are very close to 1, indicating strong linearity. | ||
| Limit of Detection (LoD), Limit of Quantitation (LoQ) | Determined consistent with CLSI EP17-A2 guidelines; proportions of false positives (α) |
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(91 days)
MVM
The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Lit-heparin, Na+citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgC class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.
Not Found
This document is a 510(k) clearance letter from the FDA for an In Vitro Diagnostic (IVD) device, specifically an ELISA test for anti-tissue transglutaminase antibodies. These types of regulatory documents typically do not contain the detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would be found in a clinical trial report or a submission summary.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This determination of substantial equivalence relies on the manufacturer providing adequate data, but the letter itself does not present that data in a public-facing way.
Therefore, I cannot extract the requested information from the provided text. The document is an FDA clearance letter and not a detailed clinical study report.
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(232 days)
MVM
The Ig plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (TG) in human serum. The test is intended for use in clinical laboratories as an aid in the disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.
The Ig plex Celiac DGP Panel is a consumable reagent kit. It is designed to run on the sqid-X system. The kit includes a microarray plate, reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The assay detects the presences of the IgA and IgG classes of antibody, and the IgA and lgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the sqid-X system that reports all analytes simultaneously to aid in the diagnosis of celiac disease.
The system is a multiplex immunoassay analyzer that semi-automates the protocol of a specific lg plex assay from plate washing to reporting of all assay markers for each individual patient sample. The system combines manual liquid handling (samples and reagents) with automated steps for washing, scanning, data analyses and reporting. Results for each patient sample are obtained simultaneously for each of the four markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
Here's a summary of the acceptance criteria and study findings for the Ig plex Celiac DGP Panel, based on the provided document:
1. Table of Acceptance Criteria & Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a go/no-go fashion with numerical targets for all performance metrics. However, it presents various performance results without indicating that they failed to meet any internal or regulatory thresholds. The following table summarizes what can be inferred as the expected performance based on the reported study results:
| Performance Metric | Acceptance Criteria (Inferred/Implied from Reported Performance) | Reported Device Performance (Ig plex Celiac DGP Panel) |
|---|---|---|
| Clinical Sensitivity | Acceptable sensitivity for each analyte | tTG IgA: 98.4% (95% CI: 97.3-99.5%) |
| tTG IgG: 46.9% (95% CI: 42.5-51.3%) | ||
| DGP IgA: 79.7% (95% CI: 76.1-83.2%) | ||
| DGP IgG: 89.1% (95% CI: 86.3-91.8%) | ||
| Clinical Specificity | Acceptable specificity for each analyte | tTG IgA: 100.0% (95% CI: 100.0-100.0%) |
| tTG IgG: 98.8% (95% CI: 98.1-99.5%) | ||
| DGP IgA: 99.2% (95% CI: 98.6-99.8%) | ||
| DGP IgG: 99.6% (95% CI: 99.2-100.0%) | ||
| Analytical Interference | Clinically acceptable recoveries (bias ≤15%) for specified interferents at given concentrations | Met for Bilirubin (0.15 mg/mL), Hemoglobin (5.00 mg/mL), Triglycerides (5.00 mg/mL), and Human IgG (0.50 mg/mL) across all analytes. |
| Method Agreement (Positive) | High positive agreement with predicate methods | tTG IgA: 100.0% (95% CI: 97.2-100.0%) |
| tTG IgG: 94.1% (95% CI: 84.1-98.0%) | ||
| DGP IgA: 93.3% (95% CI: 87.8-96.5%) | ||
| DGP IgG: 98.5% (95% CI: 94.6-99.6%) | ||
| Method Agreement (Negative) | High negative agreement with predicate methods | tTG IgA: 87.9% (95% CI: 82.5-91.8%) |
| tTG IgG: 84.6% (95% CI: 79.3-88.7%) | ||
| DGP IgA: 95.1% (95% CI: 90.9-97.4%) | ||
| DGP IgG: 90.3% (95% CI: 85.3-93.7%) | ||
| Method Agreement (Overall) | High overall agreement with predicate methods | tTG IgA: 92.9% (95% CI: 89.5-95.2%) |
| tTG IgG: 86.3% (95% CI: 81.8-89.9%) | ||
| DGP IgA: 94.3% (95% CI: 91.2-96.4%) | ||
| DGP IgG: 93.6% (95% CI: 90.4-95.7%) | ||
| Precision (Inter-assay, Lot-to-Lot, Instrument-to-Instrument) | Acceptable %CV values for various concentrations across different precision studies (generally |
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(325 days)
MVM
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of IgA and IgG antibodies to synthetic human tissue transglutaminase (1TG) and deamidated gliadin peptide (DGP) in human serum to aid in the diagnosis of celiae disease (CD) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA)
The provided text details the FDA's clearance of the ImmuLisa Enhanced Celiac Fusion (tTG/DGP) IgA/IgG Antibody ELISA for aiding in the diagnosis of celiac disease. However, the document does not contain specific acceptance criteria or a study summary that details the device's performance against such criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement.
Therefore, I cannot provide the requested information from the given text.
To address the prompt fully, I would need a study report or a different document detailing the performance evaluation of the ImmuLisa Enhanced Celiac Fusion ELISA.
Ask a specific question about this device
(247 days)
MVM
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The BioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Celiac IgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The BioPlex 2200 Celiac IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Celiac IgA Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgA Reagent Pack.
The BioPlex 2200 Celiac IgG Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgG Reagent Pack.
The BioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgA Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgA assays.
The BioPlex 2200 Celiac IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgG Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgG assays.
BioPlex® 2200 Celiac IgA and IgG kits include the following components:
One (1) 10 mL vial of Bead Set, containing dyed beads coated with recombinant antigens; an Internal Standard bead (ISB), a Serum Verification bead (SVB) and IgA Verification Bead (AVB) (in Celiac IgA only), in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with Glycerol and protein stabilizer (bovine and porcine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (
Here's an analysis of the acceptance criteria and study findings for the BioPlex® 2200 Celiac IgA and IgG kits, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a dedicated section with pass/fail thresholds. Instead, it presents performance characteristics from various studies. For this table, I will present the reported performance, which implicitly serves as the evidence that the device meets acceptable levels for these metrics. The "Target Performance" column will reflect typical expectations for such assays or the performance shown by the predicate devices where applicable.
Performance Characteristics for BioPlex® 2200 Celiac IgA and IgG Kits
| Performance Metric | Specific Assay | Reported Device Performance (Mean %CV/Values) | Target Performance (Implicit/Predicate) |
|---|---|---|---|
| Precision/Reproducibility (CLSI EP5-A2, 20 days, n=80 per sample type) | Anti-tTG IgA | Total Precision: 7.5% - 10.9% CV | Within generally accepted ranges for immunoassays (typically LoD > LoB, and values should be analytically sound for the intended use. |
| Anti-DGP IgA | LoQ: 0.2 U/mL, LoD: 0.1 U/mL, LoB: 0.0 U/mL | ||
| Anti-tTG IgG | LoQ: 0.8 U/mL, LoD: 0.8 U/mL, LoB: 0.6 U/mL | ||
| Anti-DGP IgG | LoQ: 0.4 U/mL, LoD: 0.1 U/mL, LoB: 0.0 U/mL | ||
| Clinical Sensitivity | Anti-tTG IgA | 94.9% (148/156) (95% CI: 90.2 - 97.4%) | High sensitivity for aid in diagnosis of Celiac Disease. |
| Anti-DGP IgA | 87.2% (136/156) (95% CI: 81.0 - 91.5%) | ||
| Anti-tTG IgG | 44.2% (69/156) (95% CI: 36.7 - 52.1%) | ||
| Anti-DGP IgG | 84.6% (132/156) (95% CI: 78.1 - 89.4%) | ||
| Clinical Specificity | Anti-tTG IgA | 98.8% (160/162) (95% CI: 95.6 - 99.7%) | High specificity for aid in diagnosis of Celiac Disease. |
| Anti-DGP IgA | 96.9% (158/163) (95% CI: 93.0 - 98.7%) | ||
| Anti-tTG IgG | 95.7% (155/162) (95% CI: 91.4 - 97.9%) | ||
| Anti-DGP IgG | 96.9% (158/163) (95% CI: 93.0 - 98.7%) | ||
| Method Comparison (Predicate Device) | Anti-tTG IgA (Positive Agreement) | 96.4% (163/169) (95% CI: 92.5 - 98.4%) | High agreement with legally marketed predicate devices. |
| Anti-tTG IgA (Negative Agreement) | 100% (176/176) (95% CI: 97.9 - 100%) | ||
| Anti-tTG IgA (Total Agreement) | 98.3% (339/345) (95% CI: 96.3 - 99.2%) | ||
| Anti-DGP IgA (Positive Agreement) | 97.3% (144/148) (95% CI: 93.3 - 98.9%) | ||
| Anti-DGP IgA (Negative Agreement) | 93.4% (185/198) (95% CI: 89.1 - 96.1%) | ||
| Anti-DGP IgA (Total Agreement) | 95.1% (329/346) (95% CI: 92.3 - 96.9%) | ||
| Anti-tTG IgG (Positive Agreement) | 93.3% (56/60) (95% CI: 84.1-97.4%) | ||
| Anti-tTG IgG (Negative Agreement) | 87.4% (249/285) (95% CI: 83.0 - 90.7%) | ||
| Anti-tTG IgG (Total Agreement) | 88.4% (305/345) (95% CI: 84.6-91.4%) | ||
| Anti-DGP IgG (Positive Agreement) | 93.3% (140/150) (95% CI: 88.2 - 96.3%) | ||
| Anti-DGP IgG (Negative Agreement) | 91.3% (179/196) (95% CI: 86.6 - 94.5%) | ||
| Anti-DGP IgG (Total Agreement) | 92.2% (319/346) (95% CI: 88.9 - 94.6%) |
2. Sample Size Used for the Test Set and Data Provenance:
-
Precision/Reproducibility:
- CLSI EP5-A2: 24 samples (serum panel consisting of samples spanning the measuring range), tested in replicate twice daily over 20 days (n=80 replicates per sample type).
- CLSI EP15-A2: 12 samples (serum panel consisting of samples spanning the measuring range), tested in 4 replicates per run, one run per day over 5 days (n=20 replicates per sample type).
- Lot-to-lot Reproducibility: Unspecified number of serum samples covering the assay range, tested with three reagent lots on three instruments, 10 replicates for two runs per lot (60 points per sample ID for calculation).
-
Linearity/Reportable Range: 3 low positive and 3 high positive patient serum samples for each antibody (anti-tTG IgA/IgG, anti-DGP IgA/IgG).
-
Analytical Specificity (Interference): Test substances (e.g., Hemolysate, Bilirubin, Triglycerides). No specific number of samples given for the interference study, but the substances were tested at specified concentrations.
-
Analytical Specificity (Cross-Reactivity): 244 samples from individuals with various disease states (e.g., Chronic Active Hepatitis, Crohn's Disease, Diabetes Mellitus Type 1, Rheumatoid Arthritis). The number of samples for each disease state ranged from 6 to 30.
-
Assay Cut-off Determination: 123 samples from patients with diagnosed celiac disease and 112 from non-celiac/rheumatic disease control donors. Confirmed with 298 samples from apparently healthy donors.
-
Method Comparison with Predicate Device:
- All samples: 156 patients with celiac disease, 163 patients with other rheumatic or non-CD disease control, 11 celiac IgA deficient patients, and 16 Dermatitis Herpetiformis (DH) patients. Total: 346-347 samples (1 sample excluded in some analyses).
- Samples within measuring range (and 10% diluted): Varying totals per assay, e.g., anti-tTG IgA (211), anti-DGP IgA (310), anti-tTG IgG (288), anti-DGP IgG (248).
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Clinical Studies (Sensitivity and Specificity): 319 serum specimens, including 163 non-Celiac disease control patients and 156 diagnosed Celiac disease patients.
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Expected Values/Reference Range: 300 serum samples from apparently healthy donors (139 males, 161 females, age
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(275 days)
MVM
The IgX PLEX™ Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and IgG immunoglobulin classes of anti-tissue transglutaminase antibody in serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.
The IgX PLEX™ Celiac Qualitative Assay is a consumable reagent kit. It is designed to run on the SQiDworks™ Diagnostics Platform. The kit includes a Microarray Plate, Reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The Assay Kit detects the presences of the IgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the SQiDworks™ Diagnostics Platform (platform) that reports both analytes simultaneously to aid in the diagnosis of Celiac Disease.
The platform automates the entire immunoassay procedure from end-to-end, including calibrator/standards and sample pipetting, sample dilution, incubation, washing, and drying. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for both assay markers. Results for each patient sample from the IgX PLEX™ Celiac Qualitative assay are obtained simultaneously for each of the two markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
Here's a breakdown of the acceptance criteria and study information for the IgX PLEX™ Celiac Qualitative Assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Reproducibility | Anti-tTG-IgA Reproducibility | High (not explicitly quantified but demonstrated by results) | 92.4% to 100% |
| Anti-tTG-IgG Reproducibility | High (not explicitly quantified but demonstrated by results) | 95.8% to 100% | |
| Clinical Performance | Anti-tTG-IgA Clinical Sensitivity | High (not explicitly quantified but demonstrated by results) | 98.3% |
| Anti-tTG-IgG Clinical Sensitivity | High (not explicitly quantified but demonstrated by results) | 80.9% | |
| Anti-tTG-IgA Clinical Specificity | High (not explicitly quantified but demonstrated by results) | 94.5% | |
| Anti-tTG-IgG Clinical Specificity | High (not explicitly quantified but demonstrated by results) | 89.0% | |
| Agreement with Predicates | Anti-tTG-IgA Overall Agreement | High (not explicitly quantified but demonstrated by results) | 89.3% |
| Anti-tTG-IgG Overall Agreement | High (not explicitly quantified but demonstrated by results) | 85.1% | |
| Interference | Effect of high bilirubin levels | No significant impact | None affected |
| Effect of high hemoglobin levels | No significant impact | None affected | |
| Effect of high triglycerides levels | No significant impact | None affected | |
| Effect of high human IgG levels | No significant impact | None affected |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study focuses on "clinical sensitivity" and "specificity" and "overall agreement with established predicate test systems," which suggests comparison to existing diagnostic methods rather than a panel of human experts for ground truth in the traditional sense for image-based AI.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic (IVD) assay that automates the immunoassay procedure and provides qualitative results, intended to aid in diagnosis in conjunction with other clinical findings, rather than an AI system assisting human readers of images.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance metrics reported (reproducibility, clinical sensitivity, specificity, agreement) directly reflect the standalone performance of the IgX PLEX™ Celiac Qualitative Assay. The device is an automated system described as running "from end-to-end" and generating reports with "qualitative results." Human "in-the-loop" performance in the sense of an algorithm assisting a human reader is not applicable here as it autonomously provides the diagnostic result.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth for "clinical sensitivity" and "specificity" and "overall agreement" was established by comparison to established predicate test systems and presumably clinical diagnoses of celiac disease. It does not explicitly state the ultimate "ground truth" method (e.g., small intestinal biopsy for celiac disease diagnosis, which is the gold standard). The phrase "aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings" suggests that the "true" diagnosis of celiac disease, against which the assay's performance is measured, would involve a combination of clinical information, and potentially the gold standard of biopsy.
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The sample size for the training set:
- This information is not provided. The description mentions "standards, controls, sample diluents" as part of the kit, which are generally used for calibration and quality control rather than a "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- This information is not provided. As this is an IVD assay rather than a machine learning model, the concept of a "training set" and establishing its ground truth in the typical AI/ML context doesn't directly apply in the same way.
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(286 days)
MVM
The QUANTA Flash h-tTG IgG is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IgG anti-human tissue transglutaminase (h-ITG) antibodies in human serum. The presence of IgG anti-h-tTG antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of the gluten sensitive enteropathy celiac disease, particularly in patients with selective IgA deficiency.
The QUANTA Flash™ h-tTG IgG Calibrators are intended for use with the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine values in the measurement of IgG anti-h-tTG antibodies in serum.
The QUANTA Flash™ h-tTG IgG Controls are intended for quality control purposes of the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.
Not Found
This document describes the FDA's decision to clear the QUANTA Flash™ h-tTG IgG device, along with its calibrators and controls, as substantially equivalent to legally marketed predicate devices. The document does not contain the acceptance criteria for a study proving the device meets those criteria, nor any of the detailed study information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
The FDA letter confirms that the device can be marketed based on its substantial equivalence to existing devices, implying that the provided information (not included in this excerpt) was sufficient to demonstrate this. However, it does not disclose the specific performance metrics or detailed study design used to support this claim in the way you've outlined for a typical AI/medical device acceptance criteria and study report.
Therefore, I cannot provide the requested table and study details.
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(153 days)
MVM
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It 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 Eu-tTG® IgA & Eu-tTG® IgG consists of one (1) microtiter plate (12 strips with 8 microwells coated with the human recombinant tTG 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 text describes two diagnostic devices, Eu-tTG® IgA and Eu-tTG® IgG, both intended as aids in the diagnosis of celiac disease. The study described focuses on their analytical and clinical performance.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of at least X%"). Instead, it presents the results of method comparison and clinical studies, implying that the achieved performance was deemed sufficient for substantial equivalence to predicate devices. The comparator devices' performance would implicitly serve as a benchmark for acceptability.
However, based on the provided data, we can infer performance metrics. For this response, I will list the observed performance from the clinical studies as the "Reported Device Performance." Since no explicit "acceptance criteria" are given for these values, they serve as the performance characteristics that were reviewed for market clearance.
Eu-tTG® IgA
| Performance Metric | Reported Device Performance (with Borderline Samples Considered Positive, Cut-off 9 AU/mL) | Reported Device Performance (with Borderline Samples Considered Negative, Cut-off 16 AU/mL) |
|---|---|---|
| Sensitivity (95% C.I.) | 97.5% (92.9% - 99.5%) | 85.1% (77.5% - 90.9%) |
| Specificity (95% C.I.) | 98.3% (95.8% - 99.5%) | 99.2% (97.0% - 99.9%) |
| Positive Predictive Value (PPV) (95% C.I.) | 96.7% (91.8% - 99.1%) | 98.1% (93.3% - 99.8%) |
| Negative Predictive Value (NPV) (95% C.I.) | 98.8% (96.4% - 99.7%) | 93.0% (89.2% - 95.8%) |
Eu-tTG® IgG
| Performance Metric | Reported Device Performance (Cut-off 20 AU/mL) |
|---|---|
| Sensitivity (95% C.I.) | 57% (49% - 64.6%) |
| Specificity (95% C.I.) | 94.2% (90.5% - 96.8%) |
| Positive Predictive Value (PPV) (95% C.I.) | 87.0% (79.2% - 92.7%) |
| Negative Predictive Value (NPV) (95% C.I.) | 76.3% (71.0% - 81.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Eu-tTG® IgA Clinical Study Test Set: 363 clinical samples (121 positive celiac patients, 242 negative samples).
- Eu-tTG® IgG Clinical Study Test Set: 407 clinical samples (165 positive celiac patients, 242 negative samples).
- Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were from "clinically diagnosed celiac positive" and "negative samples... from healthy blood donors, IBD patients, patients affected by food intolerances and patients with autoimmune or infectious diseases." This suggests the samples are retrospective, sourced from clinical settings or blood banks, and are clinical samples, not necessarily from a controlled prospective study for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that "The positive celiac patient samples were diagnosed with clinical findings and/or confirmed with biopsy." It does not specify the number of experts or their qualifications involved in establishing this ground truth (e.g., gastroenterologists, pathologists, etc.).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It relies on existing clinical diagnoses and biopsy confirmations.
In the method comparison studies, the "comparator test" results served as the reference for agreement calculations, but this is not an adjudication of ground truth for the clinical diagnosis itself.
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. This study focuses on the performance of a diagnostic immunoassay, not on human readers' interpretation of images or other data, with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies presented are for the standalone performance of the Eu-tTG® IgA and Eu-tTG® IgG immunoassay kits. These are in vitro diagnostic devices that directly analyze human serum samples; they do not involve a human-in-the-loop for interpreting the assay's output to render a diagnosis. The results (AU/mL values) are generated solely by the device.
7. The Type of Ground Truth Used
The ground truth for the clinical studies was established by:
- Clinical findings: This implies a physician's assessment of symptoms, medical history, and other diagnostic indicators.
- Biopsy confirmation: This refers to histological examination of intestinal tissue, which is the gold standard for diagnosing celiac disease.
- For negative samples, the ground truth was based on being "healthy subjects and patients with autoimmune disorders, infectious disease and IBD" without celiac disease.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning or AI development. These are immunoassay kits, which are typically developed and optimized through laboratory procedures, rather than being "trained" on data in the AI sense.
However, the "Assay Cut-off" section refers to testing "153 samples" (103 healthy subjects and 50 non-celiac controls) to establish the normal range and cut-off values. While not a "training set" in the AI sense, these samples were used to define parameters of the assay.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" in the typical AI sense. However, for the 153 samples used to establish cut-off values:
- Healthy subjects: Presumed to be healthy without celiac disease.
- Non-celiac controls (IBD patients): Diagnosed with IBD but implicitly confirmed not to have celiac disease.
The exact methods for establishing the "ground truth" (e.g., confirmation of health status, specific IBD diagnosis without co-occurring celiac disease) for these 153 samples are not detailed in the provided text.
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