(196 days)
(1) Elecsys Anti-TSHR immunoassay: Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Anti-TSHR immunoassay is a three step competition principle immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys PreciControl ThyroAB is a lyophilized product consisting of human serum with added Anti-TSHR antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels.
Note: The reagent and quality control material are packaged separately.
The provided document describes the Elecsys Anti-TSHR Immunoassay and its substantial equivalence to a predicate device, the BRAHMS LUMItest TRAK human Assay (K033454). The document does not clearly define explicit "acceptance criteria" in a typical clinical study sense with predetermined thresholds for sensitivity, specificity, accuracy, or other performance metrics the device must meet. Instead, it focuses on demonstrating comparable performance to a legally marketed predicate device.
The study presented is primarily a method comparison study and a precision study.
Here's an analysis of the requested information based on the provided text:
1. Table of "Acceptance Criteria" and Reported Device Performance
As mentioned, there are no explicitly stated "acceptance criteria" with numerical thresholds that the device must meet in this document. Instead, the focus is on demonstrating "substantial equivalence" through comparable performance to the predicate device. Therefore, the table below will present the performance of the Elecsys Anti-TSHR Immunoassay alongside the claimed comparable performance of the predicate device. The implied "acceptance criteria" are that the new device's performance should be similar to or better than the predicate.
| Feature | Implied "Acceptance Value" (Predicate) | Elecsys Anti-TSHR Assay Performance (Reported) |
|---|---|---|
| Precision (Within-run) | Interassay: 4.1 – 35.1% CV (samples 0.6 – 20.3 IU/L) | Elecsys 2010 and cobas e 411: |
| 5.9% CV @ 1.73 IU/L | ||
| 4.4% CV @ 2.57 IU/L | ||
| 2.7% CV @ 6.57 IU/L | ||
| 1.3% CV @ 25.5 IU/L | ||
| 3.0% CV @ 3.60 IU/L | ||
| 1.7% CV @ 15.0 IU/L | ||
| E170 and cobas e 601: | ||
| 7.6% CV @ 1.71 IU/L | ||
| 5.1% CV @ 2.16 IU/L | ||
| 1.9% CV @ 5.92 IU/L | ||
| 0.9% CV @ 24.6 IU/L | ||
| 3.1% CV @ 3.16 IU/L | ||
| 1.4% CV @ 14.6 IU/L | ||
| Precision (Total) | Intra-assay: 2.3 – 24.2% CV (samples 0.9 – 101.7 IU/L) | Elecsys 2010 and cobas e 411: |
| 9.7% CV @ 1.73 IU/L | ||
| 6.7% CV @ 2.57 IU/L | ||
| 3.9% CV @ 6.57 IU/L | ||
| 1.8% CV @ 25.5 IU/L | ||
| 5.1% CV @ 3.60 IU/L | ||
| 2.4% CV @ 15.0 IU/L | ||
| E170 and cobas e 601: | ||
| 11.4% CV @ 1.71 IU/L | ||
| 8.7% CV @ 2.16 IU/L | ||
| 3.8% CV @ 5.92 IU/L | ||
| 1.9% CV @ 24.6 IU/L | ||
| 5.5% CV @ 3.16 IU/L | ||
| 2.4% CV @ 14.6 IU/L | ||
| Measuring Range | 0.9 – 40 IU/L | 0.8 – 40 IU/L |
| LoQ (Limit of Quantitation) | 0.9 IU/L | 0.9 IU/L |
| LoB (Limit of Blank) | 0.4 IU/L | ≤0.5 IU/L |
| LoD (Limit of Detection) | NA | ≤0.8 IU/L |
| Analytical Specificity (Interference) | Anti-TG |
§ 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).