Search Results

Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer.

These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential).

This immunoassay is indicated for use as an aid in the detection of recurrent ovarian carcinoma. This immunoassay is further indicated for use in monitoring patients for disease progress or response to therapy.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzers.

For use in the verification of the callbration established by the Elecsys CA 125 II reagent on the Elecsys and cobas e immunoassay analyzers.

The CA 125 II assay employs a sandwich test principle using biotinylated monoclonal CA 125-specific antibody and a monoclonal CA 125-specific antibody labeled with a ruthenium complex to form a sandwich complex. The use of streptavidin-coated microparticles serves as the solid phase for the 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 (5-point-calibration) provided with the reagent bar code.

The CA 125 II application is identical to the predicate assay (K972162). This submission is being done to modernize the labeling by adding the LoB, LoD and LoQ data and to change the sample:reagent ratio from 40:60μL to 20:70μL. Additionally, based on internal stability data the calibration frequency has been extended from 4 to 8 weeks.

The Elecsys CA 125 II CalCheck is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2 and 3. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's a breakdown of the acceptance criteria and the study details for the Elecsys CA 125 II Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table (Table 1) between the predicate device (Elecsys CA 125 II, K972162) and the candidate device (Elecsys CA 125 II Assay), highlighting both similarities and differences, including labeled performance characteristics. Since explicit "acceptance criteria" are not given in a numerical form that can be directly compared to "reported performance" for each item, I will present the key performance characteristics detailed for the candidate device as its reported performance, implicitly indicating what was demonstrated to FDA for substantial equivalence.

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

The document details various studies performed, each with its own sample size and type:

• Precision: 4 serum samples + 2 additional serum samples for testing.
• Limit of Blank (LoB): 5 analyte-free human samples.
• Limit of Detection (LoD): 5 human samples with low analyte concentration.
• Limit of Quantitation (LoQ): 3 human sample pools.
• Linearity: 6 dilution series from 6 different spiked human samples (3 serum, 3 plasma), each with 15 dilutions.
• Dilution: 3 human samples spiked to concentrations above the measuring range.
• High Dose Hook Effect: 2 samples spiked with analyte to 50,000 U/mL, each with a dilution series.
• HAMA Effect: 1 HAMA serum and 1 basic serum (both spiked with analyte).
• Endogenous Interference: 5 interfering substances (Intralipid, Biotin, Bilirubin, Rheumatic Factor, Hemolysis) tested using 3 spiked human samples (low, medium, high) to prepare 11 dilutions.
• Exogenous Interference (Drugs): 16 common and 23 additional pharmaceutical compounds, each spiked into 2 human samples (low and high CA125 concentration).
• Exogenous Interference (Anticoagulants): 51 or 52 serum/plasma pairs for each sample material type (Serum, Li-Heparin, K2-EDTA-, K3-EDTA-plasma, Li-Heparin Plasma Separation Tubes).
• Method Comparison (Sample/Reagent Ratio Change): 80 human serum samples (native single donors).
• Method Comparison (CalSet Change): 111 human serum samples (native single donors).
• Reagent Stability:
  • After first opening: 5 human serum samples (native single donors) and 2 controls.
  • On-board: 5 human samples (pooled and single donor) and 2 controls.
  • Shelf-life: PreciControl Tumor Marker 1 and 2, using 3 reagent lots (154355-Lot, 157240, 158725).
• Sample Stability:
  • 2 to 8°C: 10 human samples for each of 4 sample types (Serum, K2-EDTA-plasma, K3-EDTA-plasma, Li-Heparin-plasma).
  • Room Temperature: 10 human samples for each of 4 sample types.
  • -20°C: 10 human samples for each of 4 sample types.
  • Freeze/Thaw: 10 human samples for each of 4 sample types.
• Calibration Stability:
  • Lot calibration: 4 human serum samples (pooled patient samples) and 2 controls.
  • On-board calibration: 5 human serum samples (pooled and single donor) and 2 controls.

Data Provenance: The document generally refers to "human samples," "human serum samples," "pooled patient samples," and "native single donors." It does not explicitly state the country of origin, but given the submitter (Roche Diagnostics) and the nature of the device (in vitro diagnostic), it's highly likely to be a combination of commercially available human samples and samples collected in clinical settings in regions where such studies are commonly performed, potentially including the US or Europe. All studies appear to be prospective for the purpose of device validation, as they involve specific experimental designs to evaluate performance characteristics.

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

This information is not provided in the document. For an immunoassay like Elecsys CA 125 II, "ground truth" typically refers to the true concentration of the analyte (CA 125) in the samples. This is usually established through reference methods, certified reference materials, or highly characterized control materials, rather than expert consensus on diagnostic images or clinical outcomes. The document mentions standardization against the Enzymun-Test CA 125 II method, which in turn was standardized against the CA 125 II RIA from Fujirebio Diagnostics. This implies a chain of reference methods rather than expert panels establishing ground truth for individual samples.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the device is an immunoassay for quantitative determination of CA 125, not a device requiring interpretation or adjudication by multiple experts (like radiology images). The "ground truth" for quantitative assays is typically established through analytical methods and reference standards, not by an adjudication process.

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 information is not applicable/not provided. The Elecsys CA 125 II Assay is an in vitro diagnostic immunoassay that quantifies a biomarker. It does not involve human readers interpreting cases or AI assistance in the context of image analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided in the context of an "algorithm only" as generally understood for AI/imaging devices. The device is a standalone automated immunoassay system (Elecsys CA 125 II Assay on the cobas e 411 analyzer) that provides quantitative results. Its "performance" is inherently "standalone" in the sense that the analyzer directly processes samples and generates results without human diagnostic interpretation input into the result generation itself. However, a clinician then interprets these results in conjunction with other clinical findings.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the quantitative measurement of CA 125 in the test samples is implicitly established by:

• Reference Methods/Standardization: The method has been standardized against the Enzymun-Test CA 125 II method, which in turn was standardized against the CA 125 II RIA from Fujirebio Diagnostics. This indicates that the "true" values used for comparison (e.g., in method comparison studies) are derived from these established reference methods.
• Spiking: For studies like linearity, dilution, hook effect, and interference, samples were "spiked" with known concentrations of the analyte, establishing a known "ground truth" for the added analyte.
• Assigned Values: For controls (e.g., PreciControl Tumor Marker), "assigned values" are used, which are derived from comprehensive characterization processes.

8. The Sample Size for the Training Set

This information is not explicitly provided in the document. For an immunoassay, "training set" might refer to data used during the assay development phase to optimize reagent concentrations, reaction times, and calibration algorithms. This type of data is usually part of internal R&D and not typically detailed in 510(k) summaries as a "training set" in the same way it would be for a machine learning model. The document primarily focuses on validation/verification studies.

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

Since the document does not explicitly mention a "training set" in the context of a machine learning algorithm, the establishment of ground truth for such a set is not applicable/not provided. If an analogous "training set" were considered to be the samples used during assay development for parameter optimization, the ground truth would likely be established using similar methods as noted in point 7 (reference methods, spiking, assigned values for controls).

Ask a specific question about this device