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510(k) Data Aggregation
(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/L4.4% CV @ 2.57 IU/L2.7% CV @ 6.57 IU/L1.3% CV @ 25.5 IU/L3.0% CV @ 3.60 IU/L1.7% CV @ 15.0 IU/LE170 and cobas e 601:7.6% CV @ 1.71 IU/L5.1% CV @ 2.16 IU/L1.9% CV @ 5.92 IU/L0.9% CV @ 24.6 IU/L3.1% CV @ 3.16 IU/L1.4% 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/L6.7% CV @ 2.57 IU/L3.9% CV @ 6.57 IU/L1.8% CV @ 25.5 IU/L5.1% CV @ 3.60 IU/L2.4% CV @ 15.0 IU/LE170 and cobas e 601:11.4% CV @ 1.71 IU/L8.7% CV @ 2.16 IU/L3.8% CV @ 5.92 IU/L1.9% CV @ 24.6 IU/L5.5% CV @ 3.16 IU/L2.4% 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 < 2000 U/mLAnti-TPO < 3000 U/mLTSH < 1000 mU/LLH < 9000 U/LFSH < 15,000 U/L | No interference with:Anti-TG if less than 4000 IU/mLAnti-TPO if less than 600 IU/mLHuman TSH if less than 1000 mIU/LHuman LH if less than 10,000 mIU/LHuman FSH if less than 10,000 mIU/LhCG if less than 50,000 mIU/mL |
| Method Comparison (Concordance) | Overall agreement 75.0% (between KRONUS TRAb and LUMItest TRAK) | Elecsys vs. BRAHMS LUMItest TRAK human:Number of samples: 212Negative Agreement: 102/109 = 93.6% (95% CI: 87.2 to 97.4)Positive Agreement: 199/199 = 100% (95% CI: 98.2 to 100)Note: 42 indeterminate results from comparative method were excluded from concordance calculations, with further analysis provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: 212 clinical samples.
- Precision (Internal Studies): The number of samples for precision evaluation is not explicitly stated but implied to be sufficient for calculating CVs at various concentrations.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "clinical samples" but doesn't specify if they are retrospective or prospective, or their geographical source.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Experts: Not applicable in the traditional sense for this type of IVD (In Vitro Diagnostic) device. The "ground truth" or reference for the method comparison study is obtained by comparing the Elecsys Anti-TSHR Immunoassay results against the predicate device (BRAHMS LUMItest TRAK human Assay). The predicate device itself acts as the "reference method" in this context.
- Qualifications: Not applicable, as expert review of samples to establish ground truth is not described.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The method comparison directly compares the quantitative output of the investigational device to the predicate device. There is no mention of human expert adjudication to resolve discrepancies between the devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for quantitative determination of TSH receptor autoantibodies, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, the performance metrics (precision, measuring range, LoQ, LoB, LoD, analytical specificity, and method comparison) presented are for the Elecsys Anti-TSHR Immunoassay operating as an automated, standalone diagnostic system. There is no human interpretation component integrated into the assay's performance claims. The "human-in-the-loop" equivalent for such an assay would be the medical professional interpreting the quantitative results in the context of a patient's clinical picture, which is outside the scope of the device's standalone analytical performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the method comparison, the "ground truth" is established by the predicate device's measurements (BRAHMS LUMItest TRAK human Assay). The document explicitly states "A comparison of the Elecsys Anti-TSHR assay (y) with BRAHMS LUMItest TRAK human (x) using clinical samples gave the following correlations." This indicates a direct comparison to an already cleared and accepted method, rather than a separate gold standard like pathology or long-term outcomes data for determining TSHR autoantibody levels.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not provided or applicable in the context of this document. This submission describes an immunoassay based on a competition principle with streptavidin-coated microparticles and electrochemiluminescence detection. It's a biochemical assay, not a machine learning or AI algorithm that typically requires a distinct training set. The reported data pertains to the validation of the finalized assay.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As it's an immunoassay technology, there isn't a "training set" in the machine learning sense. The assay development would involve optimizing reagents, protocols, and calibration, which are internal to the assay's design and not typically referred to as "training" with a distinct "ground truth" dataset in this context.
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