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510(k) Data Aggregation
(267 days)
Atellica IM Thyroglobulin (Tg)
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% observed for tested HIL substances. | |
| Interferences (Other Substances) | Bias 10% observed for tested other substances. | |
| Cross-Reactivity | Cross-reactivity |
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