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510(k) Data Aggregation
(90 days)
Elecsys Anti-TSHR
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 |
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(169 days)
ELECSYS ANTI-TSHR CALCHECK
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Anti-TSHR CalCheck is a lyophilized product consisting of human anti-TSHR antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes the 510(k) premarket notification for the Elecsys Anti-TSHR CalCheck, a quality control material. However, it does not contain detailed information regarding acceptance criteria, specific study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence to a predicate device (Elecsys C-Peptide CalCheck K040157) based on intended use, levels, format, handling, and stability. While it mentions that "The Elecsys Anti-TSHR CalCheck was evaluated for value assignment and Performance Characteristics stability," it does not provide the results of these evaluations or specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be inferred or stated based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (The document mentions evaluation for "value assignment and Performance Characteristics stability" but does not report the results or specific criteria met.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. The study was conducted by Roche Diagnostics, but the origin of the samples (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a quality control material for an immunoassay analyzer. The "ground truth" for a quality control material typically refers to its assigned value and stability characteristics, which are determined through laboratory testing and characterization. It does not typically involve human expert interpretation in the same way an imaging diagnostic device might. Therefore, the concept of "experts establishing ground truth" in this context is not directly applicable, and no information on such experts is provided.
4. Adjudication method for the test set
- Not applicable as this is a quality control material and not a diagnostic algorithm requiring human adjudication of test results.
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
- No, an MRMC study was not done. This is a quality control material, not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a quality control material (like Elecsys Anti-TSHR CalCheck) would be its assigned values for the analyte, determined through rigorous laboratory characterization and potentially traceability to reference materials. The document states it was "evaluated for value assignment," implying this type of ground truth was established by the manufacturer.
8. The sample size for the training set
- Not applicable. This is a quality control material, not an AI or machine learning algorithm that requires a training set. The "samples" described would be batches of the CalCheck material itself, which are characterized for their properties.
9. How the ground truth for the training set was established
- Not applicable, as no training set for an algorithm is involved.
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(196 days)
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
(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 |
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