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For the in vitro quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma. The Elecsys HCG STAT immunoassay is intended for use in the early detection of pregnancy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

The Elecsys HCG STAT immunoassay makes use of a sandwich test principle using monoclonal antibodies specifically directed against Human Chorionic Gonadotropin (HCG). The antibodies labeled with ruthenium complex consist of a chimeric construct from human and mouse specific components. The Elecsys HCG STAT immunoassay is used for the in vitro quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma. It is intended for use on the cobas e 601immunoassay analyzer.

The provided text describes the Elecsys HCG STAT immunoassay, its intended use, technological characteristics, and non-clinical performance evaluations conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study information as requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance, but rather lists the performance data obtained and states that "All performance specifications were met." We can infer the acceptance criteria from the context of typical FDA 510(k) submissions for in vitro diagnostics, where equivalence to the predicate and meeting standard analytical performance metrics are key.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision (21-Day): Five human serum samples (HS1-HS5) and two controls (PreciControl Universal level 1 and 2). Replicated twice per run, two runs per day for 21 days (total 84 replicates per sample/control per lot). 1 lot used.

• Precision (5-Day): Five human serum samples (HS1-HS5) and two controls (PreciControl Universal level 1 and 2). 5 aliquots per run, 1 run per day for 5 days. 3 lots used.

• Reproducibility: Six human serum samples (HSP 1-6) and two controls (CTR 1-2). 5 replicates per run, 1 run per day. 1 lot used.

• LoB (Limit of Blank): Five analyte-free samples, measured in two-fold determinations in 6 runs over ≥ 3 days. 2 different lots. Total 60 measured values per lot.

• LoD (Limit of Detection): Five low-analyte concentration samples (from LoB up to approx. 4x LoB), measured in two-fold determinations in 6 runs over ≥ 3 days. 2 different lots. Total 60 measured values per lot.

• LoQ (Limit of Quantitation): 5 human serum samples covering the range between LoB and 2x LoQ. Measured in 5 replicates, one run per day over 5 days. 2 lots evaluated.

• Linearity/Assay Reportable Range: One human serum sample (high analyte), diluted through 21 steps. Assayed in 3-fold determinations. 1 lot tested.

• High Dose Hook Effect: Three human serum samples spiked with HCG. Dilution series performed. 1 reagent lot.

• Endogenous Interferences: One lot tested on 3 samples of each interfering substance (Hemoglobin, Intralipid, Bilirubin, Rheumatoid Factors). Each HCG sample (low, medium, high) spiked with interferent in 9 dilution steps.

• Biotin Interference: Three serum samples (low, medium, high HCG concentration) spiked with biotin up to 3600 ng/mL in 11 dilution steps.

• Common Drug Interferences: One human serum sample (HCG conc. near 5 mIU/mL and near 50 mIU/mL), spiked with 17 common pharmaceutical compounds.

• Analytical Specificity/Cross-Reactivity: One human serum matrix with HCG level (5 mIU/mL) spiked with LH, FSH, TSH. 1 reagent lot.

• Sample Matrix Comparison: At least 40 serum/plasma pairs were tested in one run.

• Method Comparison to Predicate: 131 samples covering the measuring range. Tested with 1 run per sample.

• Data Provenance (Country of Origin): The document does not explicitly state the country of origin for the data. Given Roche Diagnostics' global presence, the studies could have been conducted in various locations.

• Retrospective or Prospective: These studies appear to be prospective analytical performance studies, specifically designed and executed to evaluate the device characteristics described. The phrases "Precision was evaluated...", "LoB ... was determined...", "A method comparison ... was conducted..." all indicate planned experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the Elecsys HCG STAT is an in vitro diagnostic (IVD) immunoassay, not an AI or imaging device requiring human expert ground truth for interpretation of images or clinical cases. The "ground truth" for its performance is established through quantitative measurements against known standards, spiked samples, and comparison to a legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations where there is subjective human interpretation (e.g., radiology reads) and disagreement among readers needs resolution.

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

This section is not applicable. The Elecsys HCG STAT is an automated immunoassay for quantitative determination of hCG. It does not involve human readers interpreting output that would be improved or supplemented by AI. It is a standalone diagnostic test.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was completed. The studies described (precision, detection limits, linearity, interference, method comparison) are all evaluations of the Elecsys HCG STAT immunoassay system (reagent + instrument) performance without human intervention in the measurement process. The results generated by the device are quantitative values of hCG concentration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance evaluation typically involves:

• Known concentrations: For studies like LoD, LoQ, Linearity, Interference, where samples are prepared with known, precise concentrations of hCG or interfering substances.
• Standardized materials: Traceability to the 4th International Standard for Chorionic Gonadotropin from NIBSC code 75/589.
• Quantitative measurements by a predicate device: For method comparison studies, the predicate device's results serve as a reference for comparison, establishing "ground truth" for demonstrating substantial equivalence.
• Reference measurement procedures: Although not explicitly stated, general analytical performance studies rely on highly accurate reference methods or certified reference materials where available.

8. The sample size for the training set

This section is not applicable. The Elecsys HCG STAT is an immunoassay, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The device's parameters are likely established during development and manufacturing through calibration and optimization procedures, not through a 'training set' of cases as understood in AI studies.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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The Elecsys HCG STAT CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys HCG STAT CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys HCG STAT CalCheck 5, a control solution used for calibration verification and assay range verification of the Elecsys HCG STAT reagent on specific immunoassay analyzers.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment." However, it does not explicitly define specific numerical acceptance criteria (e.g., target ranges, precision limits, deviation thresholds) for this "value assignment." Instead, it relies on the similarity of its formulation to a previously cleared device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for the "value assignment" evaluation.
• Data Provenance: Not explicitly stated. Given that it's a control solution for in-vitro diagnostics, the "test set" would refer to the characteristics of the control material itself rather than patient samples. The information indicates the device was internally evaluated by Roche Diagnostics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is generally not applicable to a control solution which is itself used to establish the "truth" of an assay's performance against known values. The "ground truth" for the control solution's own value assignment would be based on highly precise and accurate analytical methods, typically performed by expert analytical chemists or qualified laboratory personnel. The document does not specify the number or qualifications of individuals involved in the value assignment process.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which is not the case for the value assignment of an assayed control.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies compare the performance of human readers, sometimes with and without AI assistance, on diagnostic tasks. This device is an assayed control for an immunoassay, not a diagnostic imaging or interpretive AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a biochemical control solution, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the Elecsys HCG STAT CalCheck 5 is its assigned HCG concentration values. These are established through:

• Analytical Methods: Precise and accurate laboratory measurements using reference methods or highly calibrated instruments.
• Manufacturing Specifications: The analyte is "spiked into the matrix at the desired concentration levels" during manufacture, indicating a known, engineered ground truth.

8. Sample Size for the Training Set

Not applicable. This device is a control solution, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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Ask a specific question about this device