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510(k) Data Aggregation
(112 days)
Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma. The Elecsys CEA assay if further indicated for serial measurement of CEA to aid in the management of cancer patients.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37°C).
· 1st incubation (9 minutes): Sample (30 uL), biotinylated monoclonal CEA-specific antibody (60 uL), 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 uL), 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.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:
The document describes the Elecsys® CEA Assay for use on the Elecsys® 1010 immunoassay analyzer, asserting its substantial equivalence to the same assay on the Elecsys® 2010. The study presented here is a comparison study between two devices rather than a standalone study for a single device, so many of the requested categories are not directly applicable.
Description of Acceptance Criteria and Supporting Study
The acceptance criteria for the Elecsys® CEA Assay on the Elecsys® 1010 are implicitly defined by its performance characteristics being substantially equivalent to the predicate device, the Elecsys® CEA Assay on the Elecsys® 2010. The study detailed below compares these performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for a new instrument (Elecsys® 1010) using an already cleared assay (Elecsys® CEA Assay on Elecsys® 2010), the "acceptance criteria" are the performance specifications of the predicate device. The reported device performance is for the Elecsys® CEA Assay on the Elecsys® 1010.
| Feature | Acceptance Criteria (Predicate: Elecsys® 2010) | Reported Device Performance (Elecsys® 1010) |
|---|---|---|
| Precision | Modified NCCLS (ng/mL): | Modified NCCLS (ng/mL): |
| Control 1 | N=60 | N=60 |
| Within-Run | 4.9 ng/mL / 2.5 %CV | 4.44 ng/mL / 2.36 %CV |
| Total | 4.9 ng/mL / 3.6 %CV | 4.44 ng/mL / 3.07 %CV |
| Control 2 | N=60 | N=60 |
| Within-Run | 34.1 ng/mL / 1.7 %CV | 32.96 ng/mL / 1.71 %CV |
| Total | 34.1 ng/mL / 3.0 %CV | 35.51 ng/mL / 2.09 %CV |
| Pool 1 | N=60 | Not reported for Elecsys® 1010 |
| Within-Run | 2.2 ng/mL / 5.0 %CV | |
| Total | 2.2 ng/mL / 5.4 %CV | |
| Pool 2 | N=60 | N=60 |
| Within-Run | 19.6 ng/mL / 1.6 %CV | 11.86 ng/mL / 1.57 %CV |
| Total | 19.6 ng/mL / 2.3 %CV | 11.86 ng/mL / 2.83 %CV |
| Pool 3 | N=60 | N=60 |
| Within-Run | 528 ng/mL / 1.3 %CV | 113.64 ng/mL / 2.89 %CV |
| Total | 528 ng/mL / 2.0 %CV | 113.64 ng/mL / 3.97 %CV |
| Lower Detection Limit | 0.2 ng/mL | 0.2 ng/mL |
| Linearity | 0.2 - 1000 ng/mL (±10% deviation) | 0.2 - 1000 ng/mL (±10% deviation) |
| Method Comparison | (Predicate Elecsys® 2010 data) | Vs Elecsys® 2010: |
| Least Squares | y = 1.006x - 0.64; r = 0.995; N = 117 | |
| Passing/Bablok | y = 0.958x + 0.14; r = 0.995; N = 117 | |
| Hook Effect | No Hook Effect up to 200,000 ng/mL CEA | No Hook Effect up to 200,000 ng/mL CEA |
Note: The table shows that the Elecsys® 1010 assay results are generally comparable to or better than the Elecsys® 2010 for precision, except for Pools 2 and 3 where the absolute CEA values tested are different between the two instruments in the provided summary (11.86 vs 19.6 for Pool 2, and 113.64 vs 528 for Pool 3). However, the %CV values (indicating precision) remain in a similar range. For other features like lower detection limit, linearity, and hook effect, the results are identical. The method comparison directly demonstrates equivalence to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set Sample Size (N):
- For the Elecsys® 1010 and Elecsys® 2010, the precision studies used N=60 for each control/pool level (Controls 1 & 2, Pools 1, 2 & 3). This "N" represents the number of replicate measurements performed on each control/pool over the testing period.
- Method Comparison Test Set Sample Size:
- N = 117 samples were used for the method comparison study between the Elecsys® 1010 and Elecsys® 2010.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for an in vitro diagnostic, it is highly probable these were controlled prospective studies conducted in a laboratory setting by the manufacturer to validate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of in vitro diagnostic device study. The "ground truth" for an immunoassay largely relies on the accuracy of calibrators and controls traced to established reference materials, as opposed to expert human interpretation. The output is a quantitative measurement of CEA in a sample.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a quantitative measurement device, not an interpretation-based device requiring adjudication of human readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in vitro diagnostic immunoassay without human interpretation as a primary component. It is an automated quantitative measurement system; there are no "human readers" in the context of interpretation.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this is essentially a standalone (algorithm only) performance study. The device (Elecsys® CEA Assay on Elecsys® 1010) provides quantitative results without requiring human interpretation that influences the numerical outcome. The study directly evaluates the analytical performance characteristics of the physical device and its associated reagents.
7. The Type of Ground Truth Used
The ground truth for an immunoassay is established through a combination of:
- Reference Materials and Calibrators: The device's calibration curve is generated using calibrators with known concentrations, traceable to international or recognized reference materials for CEA.
- Control Materials: Quality control materials with established target values are run to monitor assay performance.
- Reference Method (for Method Comparison): In the method comparison study, the Elecsys® 2010, the legally marketed predicate device, served as the comparative "ground truth" or reference method against which the Elecsys® 1010 was evaluated.
The ultimate ground truth for a diagnostic test like CEA is based on clinical outcomes (e.g., cancer diagnosis or recurrence), but the studies presented here are analytical performance studies.
8. The Sample Size for the Training Set
Not explicitly stated. For in vitro diagnostic devices, especially immunoassay platforms, the term "training set" is usually not used in the same context as machine learning. Instead, the instrument and assay are developed and optimized through extensive R&D and internal validation using numerous samples (often a much larger set than the formal validation studies) to establish robust calibration algorithms and performance characteristics. The document presents the final validation data.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated. During the development and optimization (analogous to "training") of an immunoassay, the "ground truth" for samples used would be established using validated reference methods, internal gold standard assays, and reference materials with assigned values, often in conjunction with clinical samples that have confirmed diagnoses or outcomes. This iterative process allows for the refinement of reagents, instrument parameters, and algorithms to achieve desired performance.
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