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510(k) Data Aggregation
(166 days)
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. Elecsys proBNP II assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
The Elecsys PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers.
1.) The Elecsys proBNP II 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.
2.) The Elecsys PreciControl Cardiac II is a lyophilized product consisting of human serum with added CK-MB, Digitoxin (not for use in U.S), Digoxin, Myoglobin, and NT-proBNP 1-76 in two concentration ranges. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
3.) The Elecsys proBNP II CalSet is a lyophilized product consisting of equine serum with added NT-proBNP 1-76 in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, and quality control material are all packaged separately.
The provided document describes the Elecsys proBNP II Immunoassay, Elecsys PreciControl Cardiac II, and Elecsys proBNP II CalSet. It is a 510(k) submission seeking substantial equivalence to previously marketed devices. The study detailed focuses on comparing the performance characteristics of the new Elecsys proBNP II Assay with its predicate device, the Elecsys proBNP Immunoassay (K051382).
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the Elecsys proBNP II Assay in a formal table with pass/fail thresholds. Instead, it provides a comparative table where the performance of the new device is listed alongside that of the predicate device (Elecsys proBNP Assay, K051382). The implication is that performance comparable to or better than the predicate device constitutes meeting the criteria for substantial equivalence.
| Feature | Predicate Device (K051382) Performance | Elecsys proBNP II Assay Performance | Acceptance Criteria Met (Implicit) |
|---|---|---|---|
| Intended Use / Indication | Same as new device statement, but for older analyzer platforms | Immunoassay for in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. Aid in diagnosis of individuals suspected of having congestive heart failure. Risk stratification for acute coronary syndrome and congestive heart failure. Aid in assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure with stable coronary artery disease. | Yes (Essentially identical) |
| Analyzer Platforms | Elecsys 1010, Elecsys 2010, MODULAR ANALYTICS E170 | Elecsys 1010, Elecsys 2010 / cobas e 411, MODULAR ANALYTICS E170 (Elecsys module) / cobas e 601 (Expanded - includes newer platforms) | Yes (Expanded compatibility) |
| Assay Protocol | Sandwich Principle | Sandwich Principle | Yes |
| Detection Protocol | Electrochemiluminescent | Electrochemiluminescent | Yes |
| Traceability / Standardization | Reference standard - purified synthetic NT-proBNP (1-76) in equine serum matrix | Standardized against the Elecsys proBNP assay (predicate). | Yes (Demonstrates traceability to predicate) |
| Calibration Interval | E170/E2010: 1 month (reagent lot), 7 days (reagent kit); E1010: every reagent kit, 7 days (20-25°C), 3 days (25-32°C) | E170/E2010/cobas e analyzers: 1 month (reagent lot), 7 days (reagent kit); E1010: every reagent kit, 7 days (20-25°C), 3 days (25-32°C) (Same for relevant sections) | Yes |
| Sample Type | Human serum and plasma | Human serum and plasma | Yes |
| Reagent Stability (Unopened) | Up to stated expiration date stored at 2-8°C | Up to stated expiration date stored at 2-8°C | Yes |
| Reagent Stability (Opened) | 12 weeks at 2-8°C; 8 weeks on E170/E2010; 4 weeks on E1010 (20-25°C, up to 20 hrs total) | 12 weeks at 2-8°C; 8 weeks on E170/cobas e 601; 8 weeks on E2010/cobas e 411; 4 weeks on E1010 (20-25°C ambient temp, up to 20 hours opened in total) (Consistent for equivalent platforms) | Yes |
| Calibrator | Elecsys proBNP CalSet | Elecsys proBNP II CalSet | Yes (New equivalent calibrator) |
| Controls | Elecsys PreciControl Cardiac | Elecsys PreciControl Cardiac II | Yes (New equivalent controls) |
| Result Interpretation | 125 pg/mL (< 75 yrs), 450 pg/mL (>= 75 yrs) | 125 pg/mL for patients younger than 75 years and 450 pg/mL for patients 75 years and older | Yes |
| Measuring Range | 5-35,000 pg/mL | 5-35,000 pg/mL | Yes |
| Precision (Within run) | E170: 0.9% CV @ 474 pg/mL, 1.1% CV @ 8005 pg/mL, 0.9% CV @ 13682 pg/mL, 0.8% CV @ 208 pg/mL, 3.0% CV @ 3786 pg/mL. E1010/2010: 2.7% CV @ 175 pg/mL, 2.4% CV @ 355 pg/mL, 1.9% CV @ 1068 pg/mL, 1.8% CV @ 4962 pg/mL, 1.8% CV @ 434 pg/mL, 1.8% CV @ 6781 pg/mL. | E170 and cobas e601: 1.9% CV @ 64 pg/mL, 1.5% CV @ 124 pg/mL, 1.3% CV @ 14142 pg/mL, 1.8% CV @ 77.0 pg/mL, 1.2% CV @ 2105 pg/mL. E1010/2010 and cobas e 411: 4.2% CV @ 44.0 pg/mL, 2.4% CV @ 126 pg/mL, 1.3% CV @ 2410 pg/mL, 2.7% CV @ 33606 pg/mL, 2.58% CV @ 82.0 pg/mL, 1.18% CV @ 2318 pg/mL. | Yes (Comparable or improved at various concentrations, specifically at lower concentrations for the new device as seen by K051382 having no data for E170 that low. The new device also has data for lower and higher concentrations with similar CVs.) |
| Precision (Total) | E170: 5.8% CV @ 494 pg/mL, 4.1% CV @ 7827 pg/mL, 3.7% CV @ 13143 pg/mL, 4.5% CV @ 200 pg/mL, 3.6% CV @ 4002 pg/mL. E1010/2010: 3.2% CV @ 175 pg/mL, 2.9% CV @ 355 pg/mL, 2.6% CV @ 1068 pg/mL, 2.3% CV @ 4962 pg/mL, 2.4% CV @ 434 pg/mL, 2.2% CV @ 6781 pg/mL. | E170 and cobas e601: 3.1% CV @ 46 pg/mL, 2.7% CV @ 125 pg/mL, 1.7% CV @ 32930 pg/mL, 2.7% CV @ 77.0 pg/mL, 2.7% CV @ 2170 pg/mL. E1010/2010 and cobas e411: 4.6% CV @ 44.0 pg/mL, 2.6% CV @ 126 pg/mL, 1.8% CV @ 2410 pg/mL, 3.8% CV @ 33606 pg/mL, 2.8% CV @ 82.0 pg/mL, 1.6% CV @ 2318 pg/mL. | Yes (Comparable or improved at various concentrations, specifically at lower concentrations for the new device as seen by K051382 having no data for E170 that low. The new device also has data for lower and higher concentrations with similar CVs.) |
| Hook Effect | No effect up to 300,000 pg/mL | No effect up to 300,000 pg/mL | Yes |
| Analytical Sensitivity | 5 pg/mL | 5 pg/mL | Yes |
| Method Comparison | n.a. (predicate) | Elecsys proBNP II (y) compared to Elecsys proBNP (x): linear regression (y= 1.0x – 21.74); Passing/Bablok (y= 0.98x – 0.31) | Yes (Indicates good correlation) |
| Limit of Blank | 5 pg/mL | 1.72 pg/mL (Improved) | Yes (Improved) |
| Limit of Detection | Not explicitly listed for predicate | 2.83 pg/mL | N/A (No direct comparison, but value provided) |
| Limit of Quantitation | < 50 pg/mL | 50 pg/mL (as determined by a functional sensitivity study) | Yes (Comparable) |
| Limitations (Interference) | Bilirubin < 35 mg/dL; Hemoglobin < 1.4 g/dL; Triglycerides < 4000 mg/dL; Biotin < 30 ng/mL; RF < 1500 IU/mL | Bilirubin < 25 mg/dL; Hemoglobin < 1.0 g/dL; Intralipids < 1500 mg/dL; Biotin < 30 ng/mL; RF < 1500 IU/mL. (Slightly more restrictive for bilirubin/hemoglobin, different fat type, but generally comparable interference levels for key substances) | Yes (Comparable and acceptable for safety) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the precision studies (within-run and total precision) or the method comparison study. It provides Coefficient of Variation (CV) values at various concentration levels, implying multiple measurements were taken at each level.
The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is typical for in vitro diagnostic device submissions to involve laboratory-based studies rather than patient-level or clinical trial datasets in the same way as, for example, an imaging AI product. The studies described (precision, method comparison, analytical sensitivity, hook effect, interference) are analytical performance studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For an in vitro diagnostic device like this immunoassay, the "ground truth" for analytical performance studies is established by the methods, reference materials, and experimental design used in the lab. This is not typically an expert consensus activity in the same way it would be for an imaging study.
- For Precision, Analytical Sensitivity, Hook Effect, Interference: The ground truth is determined by the preparation of controls, calibrators, spiked samples, and reference materials with known concentrations. This does not involve "experts" in the sense of clinicians reviewing patient cases.
- For Method Comparison: The "ground truth" is the result obtained from the predicate device (Elecsys proBNP Assay, K051382). This device was already cleared by the FDA, so its results are considered an acceptable reference.
Therefore, the concepts of "number of experts" and "qualifications of those experts" are not directly applicable to this type of analytical study.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical endpoints or image interpretation where there's subjectivity and potential for disagreement among experts. For analytical performance studies of an immunoassay, results are quantitative and determined by the instrument and assay chemistry. Discrepancies would be resolved through re-testing, investigation of instrument error, or re-calibration, not expert adjudication of a "diagnosis."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with vs. without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI-driven diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for an in vitro diagnostic immunoassay, which provides quantitative results directly from a blood sample and does not involve human "readers" interpreting output in the same clinical sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
For an in vitro diagnostic assay, the "standalone performance" is precisely what the analytical performance studies describe. The device (immunoassay on an analyzer) operates without human interpretation of its raw output to generate the quantitative result. The precision, analytical sensitivity, method comparison, hook effect, and interference studies demonstrate the device's performance in this standalone capacity.
7. The Type of Ground Truth Used
The ground truth used for the analytical validation of the Elecsys proBNP II Immunoassay includes:
- Reference Materials: For analytical sensitivity and potentially for method comparison, the device is likely compared against defined synthetic or purified NT-proBNP standards.
- Predicate Device Results (Elecsys proBNP Assay, K051382): For the method comparison study, the results from the predicate device are used as the reference standard. This is a common form of "ground truth" for establishing substantial equivalence in 510(k) submissions for IVDs.
- Spiked Samples: For interference studies, samples are "spiked" with known interferents at defined concentrations.
- Control Materials: Used to assess precision and stability, with target values established through rigorous characterization.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily applicable to machine learning or AI models. This submission is for a traditional immunoassay, which does not involve a training set in that sense. The device's internal parameters and calibration curves are established through a development and validation process, but this is distinct from "training data" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI/ML context for this device, this question is not applicable. The assay's fundamental operating characteristics are based on established immunoassay principles, reagent formulation, and instrument design, which are validated through the analytical performance studies mentioned. The device uses a "master curve" provided with the reagent bar code, and a 2-point calibration is performed on each instrument. This calibration process establishes the relationship between signal and concentration, which is a form of internal "training" or standardization using known calibrators, but not in the sense of a dataset for an algorithm.
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