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510(k) Data Aggregation
(80 days)
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(264 days)
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(261 days)
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(231 days)
The Alegria Flash CTD Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to SSA-60, SSA-52, SS-B, Jo-1, Scl-70, SmRNP, Sm, dsDNA, Ribosomal P, Nucleosome, and Centromere-B in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD): Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Limited Cutaneous Systemic Sclerosis (CREST Syndrome), polymyositis, and dermatomyositis along with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
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(262 days)
The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system.
Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and/or Graves' disease.
The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) consists of:
- aTPOII ReadyPack® primary reagent pack (Lite Reagent, Solid Phase)
- aTPOII CAL
Devices sold separately and included in the ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII) are: - ADVIA Centaur aTPOII MCM (MCM 1, MCM 2–4)
- ADVIA Centaur aTPOII QC
- ADVIA Centaur aTPOII DIL ReadyPack ancillary reagent pack
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(269 days)
Immunoglobulin Isotypes (GAM) for the EXENT Analyser:
The Immunoglobulin Isotypes (GAM) for the EXENT Analyser is a MALDI-TOF mass spectrometry immunoassay that is used in conjunction with the Binding Site Optilite IgG, IgA and IgM assays for the semi-quantitative in vitro measurement of monoclonal IgG, IgA, and IgM as a reflex test in serum for patients with a result suggestive of the presence of monoclonal immunoglobulins by serum protein electrophoresis (gel or capillary zone electrophoresis), or with an abnormal serum free light chain concentration and free light chain ratio result.
The assay is intended for use as an aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS); and as an aid in the diagnosis of smouldering multiple myeloma (SMM), multiple myeloma (MM), Waldenström's macroglobulinaemia, and AL amyloidosis.
Assay results should be used in conjunction with other laboratory and clinical findings.
EXENT Analyser:
The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. The device is designed for professional in vitro diagnostic use only and it is not a device for self-testing.
The system consisting of the EXENT® Analyser and the EXENT® assays are intended for the in vitro measurements of analytes in human body fluids. It is designed to provide automation and integration of all the analytical steps (including liquid handling and MALDI-ToF mass spectrometry). The EXENT Analyser is designed to be used solely in combination with EXENT assays to measure a variety of analytes depending on the reagents. The device is designed for professional use only and it is not a device for self-testing.
The EXENT Analyser combines automated immunoassay with readout by MALDI-ToF mass spectrometry. It is a modular analyser, and the major components are described in Table 3 and illustrated schematically in Figure 1.
| Component | Description | Function |
|---|---|---|
| EXENT-iP® 500 | Automated liquid handler | Preparation of patient samples by magnetic bead immunoprecipitation assays for subsequent analysis by MALDI-ToF Mass spectrometry |
| EXENT-iX® 500 | MALDI-ToF mass spectrometer | Analysis of prepared patient samples by MALDI-ToF mass spectrometry |
| EXENT-iQ® software | Workflow and data management software | Management of the workflow between the EXENT-iP500 and EXENT-iX500 instruments. Data management including processing and results release. |
The EXENT-iP500 component is an automated liquid handler that prepares human body fluids using the EXENT assay specific reagents. The samples are prepared using magnetic beads that are coated with isotype-specific antibodies. Any unbound material is washed away during the sample preparation process. The EXENT-iP500 also manages the transfer of the prepared patient sample to the MALDI plate.
The EXENT-iX500 component is a MALDI-ToF mass spectrometer. Signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. The EXENT-iX500 is used to read samples prepared by the EXENT-iP500.
The EXENT-iQ software integrates sample preparation and MALDI-ToF mass spectrometry and is used for data storage and processing. It is the primary user interface used by the user to review and release results.
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(90 days)
Elecsys Phospho-Tau (181P) Plasma is an in vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein in human plasma on cobas e immunoassay analyzers.
The Elecsys Phospho-Tau (181P) Plasma assay result is intended to be used as an aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.
A negative test result is consistent with a negative amyloid positron emission tomography (PET) scan result and reduced likelihood that a patient's cognitive impairment is due to amyloid pathology. These patients should be investigated for other causes of cognitive decline.
A positive test result may not be consistent with a positive amyloid PET scan result. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.
In vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein (pTau181p) in human plasma.
Elecsys Phospho-Tau (181P) Plasma utilizes a sandwich test principle and has a total duration time of 18 minutes.
- 1st incubation: 30 µL of sample, biotinylated monoclonal antibody specific for phosphorylation at threonine 181, and a monoclonal tau-specific antibody labeled with a ruthenium complex^a) react to form a sandwich complex.
- 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
- The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
- Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the cobas link.
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(218 days)
The Alegria Flash ENA Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, or SmRNP in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD) Sjögren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Limited Cutaneous Systemic Sclerosis (CREST Syndrome), polymyositis, and dermatomyositis along with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
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(267 days)
The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer.
Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
The Atellica IM Thyroglobulin (Tg) assay includes:
- Tg ReadyPack primary reagent pack:
- Lite Reagent: mouse monoclonal anti-human Tg antibody labeled with acridinium ester (~1.13 μg/mL); bovine serum albumin (BSA); mouse IgG; buffer; stabilizers; preservatives (7.5 mL/reagent pack).
- Solid Phase: streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody (~267 μg/mL); BSA; mouse IgG; buffer; stabilizers; preservatives (15.0 mL/reagent pack).
- Ancillary Well Reagent: BSA; bovine gamma globulin; buffer; preservatives (6.0 mL/reagent pack).
- Tg CAL: After reconstitution, human thyroglobulin; BSA; buffer; stabilizers; preservatives (2.0 mL/vial).
The following devices are sold separately:
- Atellica IM Tg MCM:
- MCM 1: After reconstitution, bovine serum albumin (BSA); buffer; stabilizers; preservatives (1.0 mL/vial).
- MCM 2–5: After reconstitution, various levels of human thyroglobulin; BSA; buffer; stabilizers; preservatives (1.0 mL/vial).
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Atellica IM Thyroglobulin (Tg) assay:
Device: Atellica IM Thyroglobulin (Tg) Assay
Purpose: Quantitative measurement of thyroglobulin in human serum and plasma as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes various performance characteristics, which serve as acceptance criteria for the device. The reported performance is directly from the summary.
| Acceptance Criteria Category | Specific Acceptance Criteria (implicit from study design) | Reported Device Performance |
|---|---|---|
| Detection Capability | LoB, LoD, LoQ determined per CLSI EP17-A2 | LoB: 0.039 ng/mL (0.059 pmol/L) LoD: 0.044 ng/mL (0.067 pmol/L) LoQ: 0.050 ng/mL (0.076 pmol/L) |
| Precision | Precision determined per CLSI EP05-A3 (within-laboratory and repeatability) | Repeatability (CV%): 1.2% - 6.4% across various concentrations Within-Laboratory Precision (CV%): 2.3% - 9.0% across various concentrations |
| Reproducibility | Reproducibility determined per CLSI EP05-A3 (across sites, runs, days) | Reproducibility (CV%): 1.9% - 5.8% across various concentrations |
| Linearity | Linearity determined per CLSI EP06-ed2 within stated assay range | Linear for 0.050–150 ng/mL (0.076–227 pmol/L) |
| Specimen Equivalence | Performance equivalence across serum, EDTA plasma, lithium heparin plasma | Performance confirmed equivalent across serum, EDTA plasma, lithium heparin plasma, and associated gel barrier tubes. |
| Interferences (HIL) | Bias < 10% for Hemoglobin, Bilirubin, Lipemia at specified concentrations | No bias > 10% observed for tested HIL substances. |
| Interferences (Other Substances) | Bias < 10% for various common substances/medications/biomarkers at specified concentrations | No bias > 10% observed for tested other substances. |
| Cross-Reactivity | Cross-reactivity < 1.0% for specified substances (T3, T4, TSH, Galectin-3, T2) | Cross-reactivity < 1.0% for tested substances. |
| Reagent Stability | Defined on-board and reconstituted calibrator stability | 28 days on-board; Calibrators stable 45 days (2-8°C) / 60 days (≤ -20°C, thaw once). |
| Sample Stability | Defined stability for various sample types and storage conditions | Stable 3-4 days (2-8°C), 4 days (RT), 12-24 months (frozen); ≤ 4 freeze-thaw cycles. |
| High Dose Hook Effect | No hook effect within a specified concentration range | No hook effect up to 80,000 ng/mL (121,200 pmol/L). |
| Expected Values | Reference intervals established per CLSI EP28-A3c | Healthy Adults: 2.44–74.9 ng/mL Post-thyroidectomy adults: < 1.27 ng/mL |
| Clinical Performance | Sensitivity and specificity calculated by comparing assay results to structural disease (SD) at a defined cut-off (0.2 ng/mL). Confidences intervals for these parameters. | Sensitivity: 98.2% (95% CI: 94.6%, 100.0%) Specificity: 53.4% (95% CI: 47.8%, 58.0%) PPV: 10.0% (95% CI: 8.7%, 11.2%) NPV: 99.8% (95% CI: 99.5%, 100.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Performance Test Set Sample Size: 291 serum samples collected from 189 subjects.
- Data Provenance:
- The document states "A prospective, multi-center study was conducted." This indicates prospective data collection across multiple sites.
- The country of origin is not explicitly stated in the provided text.
- All samples were from subjects diagnosed with differentiated thyroid cancer, 6 or more weeks following thyroidectomy or radioiodine ablation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts or their qualifications for establishing the ground truth (structural disease). It simply states: "SD [Structural Disease] was established and classified as either positive or negative by cross-sectional or functional imaging results."
- This suggests that the ground truth was derived from standard clinical imaging reports rather than a consensus of independent expert readers specifically for this study.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the test set's ground truth (structural disease). It implies that the imaging results themselves provided the classification. This means there was no adjudication process as typically seen with multiple human readers reviewing images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done.
- This study is for an in vitro diagnostic (IVD) assay (a lab test), not an AI-assisted imaging or diagnostic tool where human readers work with or without AI. The performance metrics presented are for the analytical and clinical performance of the assay itself, comparing its results to a ground truth (structural disease status), not to human reader performance or improvement with AI.
6. If a Standalone Performance Study Was Done
- Yes, this is effectively a standalone (algorithm only) performance study.
- The Atellica IM Tg assay is an automated in vitro diagnostic device. Its performance characteristics (sensitivity, specificity, precision, linearity, etc.) are evaluated intrinsically, independent of human interpretation of the assay result values. The output is a quantitative measurement of thyroglobulin.
7. The Type of Ground Truth Used
- Ground truth for clinical performance: Structural disease (SD) status obtained from "cross-sectional or functional imaging results."
- Ground truth for analytical performance (LoB, LoD, LoQ, Precision, etc.): Established through laboratory protocols and reference materials (e.g., CLSI guidelines, certified reference materials like BCR CRM 457, spiked samples, control materials).
8. The Sample Size for the Training Set
- The document does not specify a separate training set or its sample size for the Atellica IM Tg assay.
- For IVD assays like this, the "training" is typically inherent in the assay's development and optimization process (e.g., reagent formulation, calibration curve development), which uses various known samples and standards, rather than a distinct, labeled "training dataset" as would be seen for a machine learning algorithm. The performance characteristics studies presented are akin to a "verification/validation set."
9. How the Ground Truth for the Training Set Was Established
- As a traditional IVD assay, there isn't a "training set" in the sense of a machine learning model.
- Ground truth for assay development and calibration: This would have been established using reference materials (like BCR CRM 457), characterized control samples, and potentially a large panel of clinically characterized patient samples used during the assay's development and optimization phases. These activities are part of the broader product development lifecycle rather than a distinct "training set" with ground truth generated by experts in the context of a clinical study for submission. Standardization is explicitly noted as traceable to BCR CRM 457, which serves as a primary standard for establishing the quantitative accuracy of the assay.
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(356 days)
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