(90 days)
Immunoassay for the in vitro quantitation of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzers.
The Elecsys Anti-TSHR is used for the in vitro quantitative determination of autoantibodies to TSHR receptor in human serum using a human thyroid stimulating monoclonal antibody. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers uses electrochemiluminescence immunoassay "ECLIA" technology.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Elecsys Anti-TSHR device:
Acceptance Criteria and Device Performance for Elecsys Anti-TSHR
The Elecsys Anti-TSHR is an immunoassay for the in vitro quantitative determination of autoantibodies to the TSH receptor in human serum, used in the assessment of patients suspected of Graves' disease.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit from study results meeting "predetermined acceptance criterion") | Reported Device Performance |
|---|---|---|
| Precision | All samples to meet predetermined acceptance criteria for repeatability and intermediate imprecision. | Repeatability: Sample 1: 0.105 IU/L SD (7.5% CV); Sample 2: 0.140 IU/L SD (7.5% CV); Sample 3: 0.114 IU/L SD (5.7% CV); Sample 4: 0.252 IU/L SD (1.1% CV); Sample 5: 0.298 IU/L SD (0.8% CV); PC ThyroAB 1: 0.145 IU/L SD (3.3% CV); PC ThyroAB 2: 0.342 IU/L SD (1.9% CV). |
| Intermediate Precision: Sample 1: 0.129 IU/L SD (9.1% CV); Sample 2: 0.161 IU/L SD (8.6% CV); Sample 3: 0.144 IU/L SD (7.2% CV); Sample 4: 0.347 IU/L SD (1.5% CV); Sample 5: 0.505 IU/L SD (1.3% CV); PC ThyroAB 1: 0.178 IU/L SD (4.0% CV); PC ThyroAB 2: 0.397 IU/L SD (2.2% CV). | ||
| Lot-to-Lot Reproducibility: "Calculated SD´s and CV´s for the multiple lot (reproducibility) study are comparable to those of the single lot (intermediate) precision study (met acceptance)." | ||
| Analytical Sensitivity | Each lot to meet the predetermined acceptance criterion. | Limit of Blank (LoB): All lots met acceptance. Claim set to 0.5 IU/L. |
| Limit of Detection (LoD): All lots met acceptance. Claim set to 0.8 IU/L. | ||
| Limit of Quantitation (LoQ): All lots met acceptance. Claim set to 1.1 IU/L. | ||
| Linearity/Reportable Range | Deviations to be within predetermined acceptance criteria across the entire measuring range. | Linearity confirmed in the range from 0.8 to 40.0 IU/L (all deviations within predetermined acceptance criteria). |
| High Dose Hook Effect | Not applicable. | Not applicable (device is not susceptible). |
| HAMA Interference | Not susceptible to interference from HAMA. | Not susceptible to interference from Human Anti-Mouse Antibodies (HAMA). |
| Endogenous Interference: | Recovery for each sample to meet "predetermined acceptance criterion" (implicit). | Biotin: Claim set to |
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).