(161 days)
IMMUNOASSAY
Immunoassay for the in vitro quantitative determination of CA 19-9 turnor associated antigen, in human serum and plasma.
The assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in the monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
CALSET
Elecsys CA 19-9 is used for calibrating the quantitative Elecsys CA 19-9 assay on the Elecsys immunoassay systems.
The Elecsys CA 19-9 Assay is a two step sandwich immunoassay with streptavidin 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the comparison to the predicate device. The study aims to demonstrate substantial equivalence, meaning the Elecsys CA 19-9 system performs with comparable characteristics to the legally marketed Fujirebio CA 19-9 RIA.
| Feature / Acceptance Criteria (vs. Predicate) | Elecsys CA 19-9 Performance (Reported) | Fujirebio CA 19-9 RIA (Predicate Performance) |
|---|---|---|
| Intended Use | In vitro quantitative determination of CA 19-9 tumor-associated antigen in serum and plasma. | In vitro quantitative determination of CA 19-9 tumor-associated antigen in serum and plasma. |
| Indication for Use | An aid in the management of patients with cancers of the exocrine pancreas. | An aid in the management of patients with cancers of the exocrine pancreas. |
| Assay Principle | Electrochemiluminescent immunoassay | Radioimmunoassay |
| Sample Type | Human serum and plasma | Human serum and plasma |
| Measuring Range (Analytical Range) | 0.60 - 1000 U/mL | 0.9 - 240 U/mL |
| Precision (Within-run CV) - 1010/2010 | 2.9%-4.8% CV @ 11.1-185.4 U/mL | Average variability ranged from 6.7% (44 U/mL) to 15.4% (8 U/mL). |
| Precision (Total Precision CV) - 1010/2010 | 2.9%-4.4% CV @ 11.1-185.4 U/mL | Average variability ranged from 6.7% (44 U/mL) to 15.4% (8 U/mL). |
| Precision (Within-run CV) - E170 | 1.2%-2.5% CV @ 5.2-379 U/mL | Average variability ranged from 6.7% (44 U/mL) to 15.4% (8 U/mL). |
| Precision (Total Precision CV) - E170 | 1.9%-8.0% CV @ 5.57-371 U/mL | Average variability ranged from 6.7% (44 U/mL) to 15.4% (8 U/mL). |
| Analytical Sensitivity (LDL) | 0.60 U/mL | 0.9 U/mL |
| Hook Effect | No high dose hook effect up to 500,000 U/mL | None up to 1,250,000 U/mL |
| Interference (Icterus) | Unaffected by icterus (bilirubin 5mg/day doses. | (Not explicitly stated for predicate in comparison table) |
| Interference (Rheumatoid Factors) | No interference from rheumatoid factors up to 1500 IU/mL. | (Not explicitly stated for predicate in comparison table) |
| Interference (Pharmaceuticals) | No interference found from 27 commonly used pharmaceuticals. | (Not explicitly stated for predicate in comparison table) |
| Interference (HAMA/Heterophilic antibodies) | Additives minimize effects of monoclonal mouse antibodies; rare interference from antibodies to streptavidin and ruthenium. | May show false elevated/depressed values with HAMA; requires careful evaluation. |
Study Proving Device Meets Acceptance Criteria:
The provided text describes a submission for substantial equivalence to a predicate device (Fujirebio Diagnostics CA 19-9 RIA, cleared under K020566). The study is not detailed as a separate clinical trial but through a direct comparison of the performance characteristics of the Elecsys CA 19-9 Immunoassay with the predicate device. The underlying assumption is that if the new device demonstrates comparable or superior performance across these key analytical metrics, it is "substantially equivalent" and thus meets the acceptance criteria for market clearance.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the various performance characteristic tests (precision, analytical sensitivity, hook effect, interference studies). Similarly, data provenance (country of origin, retrospective/prospective) is not mentioned. This is common for this type of 510(k) summary, as it focuses on the analytical performance values rather than the specific study design details like subject recruitment or data collection methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given this is an in vitro diagnostic (IVD) device for quantitative determination of a biomarker (CA 19-9), the "ground truth" for the test set is established through reference methods or known concentrations of the analyte in control materials or patient samples with confirmed clinical status, rather than expert interpretation of images or other subjective data. Therefore, the concept of "experts establishing ground truth" in the way it applies to image-based diagnostics (e.g., radiologists) is not applicable here. The ground truth would be chemical/analytical, often determined by highly accurate laboratory methods or certified reference materials.
4. Adjudication Method for the Test Set
As this is an IVD device measuring a quantitative biomarker, adjudication by human experts (like 2+1 or 3+1 consensus) is not applicable. The "ground truth" for analytical performance studies is based on established laboratory methods, standard reference materials, or clinically characterized samples, against which the device's measurements are compared.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was done or is applicable here. This study pertains to a standalone in vitro diagnostic immunoassay that quantifies a biomarker. It is not an AI-assisted diagnostic tool for human readers interpreting complex medical data (like images). Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done. The entire summary describes the analytical performance of the Elecsys CA 19-9 Immunoassay as an algorithm-only (device-only) system. Its reported precision, analytical sensitivity, measuring range, and interference characteristics are inherent to the device's technical operation, without direct human intervention in the measurement process itself. The "human-in-the-loop" aspect exists in the medical professional interpreting the quantitative result in the context of a patient's overall clinical picture, but the device's performance metrics are standalone.
7. The Type of Ground Truth Used
The ground truth used for evaluating this immunoassay would be based on:
- Known concentrations of CA 19-9 in assayed controls and calibrators.
- Reference methods or established laboratory methods for samples used in comparisons (e.g., external quality assessment programs, or comparison to the predicate device).
- Clinically characterized patient samples for assessing agreement with clinical status or disease progression (though specific details of such studies are not provided in this summary, the intended use implies this clinical correlation).
The summary itself primarily focuses on analytical performance against established laboratory standards and comparisons to the predicate device.
8. The Sample Size for the Training Set
The document does not provide information on a specific "training set" sample size. For an immunoassay like this, the development process involves extensive internal validation and optimization, but the concept of a distinct "training set" as understood in machine learning (where algorithms learn from data) does not directly apply in the same way. The performance characteristics described are the result of the device's engineering and chemical design, validated against samples to establish its specifications.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning sense is not explicitly referenced or described for this immunoassay, information on how its ground truth was established is not available in the provided text. The development of such an immunoassay involves optimizing reagents, reaction conditions, and calibration procedures to accurately measure CA 19-9. This optimization would rely on accurately prepared samples with known CA 19-9 concentrations, established through internal reference methods and material characterization.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.