(227 days)
Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma.
Measurements of CEA aid in the management of cancer patients by monitoring CEA concentrations.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal CEA-specific antibody (60 µL), and a monoclonal CEA-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex.
• 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (50 µL), the complex is bound to the solid phase via interaction of biotin and streptavidin.
• The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
• Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
The provided document is a 510(k) summary for the "Elecsys® CEA Assay," a device for the in vitro quantitative determination of carcinoembryonic antigen (CEA). The document focuses on demonstrating substantial equivalence to a predicate device (Enzymun-Test CEA Assay) rather than establishing specific acceptance criteria for a new device and proving its performance against these criteria through a dedicated study.
Therefore, much of the requested information regarding acceptance criteria, a standalone study to prove acceptance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not explicitly stated in the document as it would be for a novel device undergoing a performance study.
However, I can extract information related to performance characteristics that were compared between the new device and the predicate device, which can be interpreted as demonstrating that the new device performs comparably to an already accepted device.
Here's the closest interpretation of your request based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify "acceptance criteria" in the sense of predefined thresholds that the Elecsys® CEA Assay must meet to be approved. Instead, it presents performance characteristics of the Elecsys® CEA Assay and directly compares them to a legally marketed predicate device (Enzymun-Test CEA Assay) to demonstrate substantial equivalence. The implication is that if the new device's performance characteristics are comparable to or better than the predicate, it is considered acceptable.
| Performance Characteristic | Elecsys® CEA Assay Performance | Predicate Device (Enzymun-Test CEA Assay) Performance | Implied Acceptance Criterion (Comparability to Predicate) |
|---|---|---|---|
| Precision | %CV and values comparable to predicate | ||
| Control 1 (5.10 ng/mL) | Within-Run %CV: 1.8%, Total %CV: 3.5% | Low (2.3 ng/mL) Within-Run %CV: 5.6%, Total %CV: 6.3% | Lower or comparable %CVs |
| Control 2 (35.51 ng/mL) | Within-Run %CV: 1.4%, Total %CV: 2.8% | Mid (12.4 ng/mL) Within-Run %CV: 3.7%, Total %CV: 4.1% | Lower or comparable %CVs |
| Pool 1 (3.99 ng/mL) | Within-Run %CV: 1.7%, Total %CV: 3.2% | High (26.4 ng/mL) Within-Run %CV: 3.3%, Total %CV: 3.7% | Lower or comparable %CVs |
| Pool 2 (17.16 ng/mL) | Within-Run %CV: 1.7%, Total %CV: 3.2% | N/A | |
| Pool 3 (546.00 ng/mL) | Within-Run %CV: 1.4%, Total %CV: 3.4% | N/A | |
| Lower Detection Limit | 0.2 ng/mL | 0.5 ng/mL | Lower or comparable detection limit |
| Linearity Range | 0.2 - 1000 ng/mL (±10% deviation) | 0.5 - 55 ng/mL (±10% deviation) | Wider or comparable linear range |
| Method Comparison (vs. Enzymun-Test® CEA) | 0-50 ng/mL: y=1.25x - 0.86, r=0.976 (N=397) | y=0.97x - 0.064, r=0.989 (N=69) | High correlation (r value) and acceptable regression parameters |
| 0-600 ng/mL: y=1.05x + 0.46, r=0.991 (N=446) | |||
| Interfering Substances (Bilirubin) | No interference at 25 mg/dL | No interference at 64.5 mg/dL | Comparable or higher tolerance for interference |
| Interfering Substances (Hemoglobin) | No interference at 1000 mg/dL | No interference at 50 mg/dL | Higher tolerance for interference |
| Interfering Substances (Lipemia) | No interference at 1000 mg/dL | No interference at 1250 mg/dL | Comparable or higher tolerance for interference |
| Interfering Substances (Biotin) | No interference at 30 ng/mL | No interference at 40 ng/mL | Comparable or higher tolerance for interference |
| Specificity (NCA 1 cross-reactivity) |
§ 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.