Search Results
Found 2 results
510(k) Data Aggregation
(458 days)
Immunoassay for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used as an aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy). The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
The Tg II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal Tg-specific antibody and monoclonal Tg-specific antibodies labeled with a ruthenium complex. The Tg II immunoassay is intended for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy). It is intended for use on the cobas e immunoassay analyzers. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode or e-barcode.
The Elecsys Tg II device is an immunoassay intended for the in vitro quantitative determination of thyroglobulin in human serum and plasma, used as an aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for all performance measures in a comparative table against the reported performance. However, based on the studies conducted and their results, one can infer the implicit acceptance criteria by observing the measured performance and statements like "All deviations from linearity met the specification" or "Non-significant interferences were defined as %interferences within ± 10 %".
Below is a table summarizing the reported device performance, with inferred acceptance criteria where direct ones are not explicitly stated, but are implied by the reported "met specifications" or similar statements.
| Performance Characteristic | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | ||
| Sensitivity | High sensitivity required for monitoring recurrent/metastatic disease (e.g., >90%). | 98.91% (91/92) with 95% CI: (94.10%; 99.81%) |
| Specificity | Acceptable specificity for the intended use (the exact value is not explicitly stated as an initial acceptance criterion, but the reported value is presented as performance). | 53.42% (234/438) with 95% CI: (48.74%; 58.05%) |
| Negative Predictive Value (NPV) | High NPV desired for ruling out disease (-ve result, truly -ve). | 99.89% with 95% CI: (99.42%; 99.98%) (calculated at 4.99% prevalence) |
| Positive Predictive Value (PPV) | Acceptable PPV for the intended use. | 10.03% with 95% CI: (9.16%; 11.03%) (calculated at 4.99% prevalence) |
| Analytical Performance | ||
| Limit of Blank (LoB) | Must be very low (e.g., in the picogram/mL range) to detect low levels of Tg. No explicit criterion given, but the reported value is the outcome of the study designed to determine it. | 0.02 ng/mL (Determined according to CLSI EP17-A2) |
| Limit of Detection (LoD) | Must be very low, enabling early detection of disease recurrence. No explicit criterion given, but the reported value is the outcome of the study designed to determine it. | 0.04 ng/mL (Determined according to CLSI EP17-A2) |
| Limit of Quantitation (LoQ) | %CV of within-laboratory precision ≤ 20% and %bias within ±15%. | 0.1 ng/mL (%CV for samples around this level ranged from 7.56% to 4.00% for repeatability, and within-laboratory CVs were 9.34%, 8.75%, 5.67% for HS1, HS2, HS3 respectively, all below 20%. Bias not explicitly shown in summary table but met criteria.) |
| Linearity | Deviations from linearity ≤ ±10% for values ≥0.3 ng/mL and within ±0.03 ng/mL for values |
Ask a specific question about this device
(529 days)
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
Access Thyroqlobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent /metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidin |
| and coupled to biotinylated mouse monoclonal | |
| antithyroglobulin antibodies, suspended in a TRIS buffer with | |
| protein (bovine), |
The provided text describes the Beckman Coulter Access Thyroglobulin assay, a chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum. This device is intended to aid in monitoring for persistent or recurrent/metastatic differentiated thyroid cancer (DTC) in patients who have undergone thyroid surgery and lack serum thyroglobulin antibodies.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance for all aspects. Instead, acceptance criteria are generally mentioned within the description of each study. Below is a compilation of the criteria and reported performance for key studies.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R ≥ 0.90 and slope 1.00 ± 0.09 | Met (R and slope not explicitly provided but stated as met) |
| High-dose Hook Effect | No high-dose hook effect | No high-dose hook effect at concentrations up to at least 40,000 ng/mL |
| Reference Range | Linear across the range of the assay | Linear across the range of the assay (0.1 to approximately 500 ng/mL) |
| Limit of Blank (LoB) | ≤ 0.03 ng/mL | 0.02 ng/mL |
| Limit of Detection (LoD) | ≤ 0.05 ng/mL | 0.05 ng/mL |
| Limit of Quantitation (LoQ) | ≤ 0.1 ng/mL | 0.05 ng/mL |
| Analytical Specificity (Cross-reactivity) | Change in concentration between diluent control and test samples within ± 10% | No significant cross-reactivity for T3, T4, TBG, TSH |
| Analytical Specificity (Interference) | Change in concentration between diluent control and test samples within |
Ask a specific question about this device
Page 1 of 1