(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) | 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 |
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”