(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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K672437
510(k) Summary
FEB - 5 2008
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ||
|---|---|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521-3544 | ||
| Contact Person: Kay Taylor | |||
| Date Prepared: January 28, 2008 | |||
| Device Name | Proprietary name: 1.) Elecsys® proBNP II Immunoassay2.) Elecsys® PreciControl Cardiac II3.) Elecsys® proBNP II CalSetCommon name:1.) proBNP Assay2.) PreciControl Cardiac1.) proBNP CalSetClassification name: 1.) Test, Natriuretic Peptide2.) Multi-Analyte Controls, All Kinds (Assayed andUnassayed)3.) Calibrator, Secondary |
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| Description | 1.) The Elecsys proBNP II Assay is a two step sandwich immunoassay withstreptavidin microparticles and electrochemiluminescence detection.Results are determined using a calibration curve that is generatedspecifically on each instrument by a 2 point calibration and a master curveprovided with the reagent bar code.2.) The Elecsys PreciControl Cardiac II is a lyophilized product consisting ofhuman 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 desiredconcentration levels.3.) The Elecsys proBNP II CalSet is a lyophilized product consisting ofequine serum with added NT-proBNP 1-76 in two concentration ranges.During manufacture, the analyte is spiked into the matrix at the desiredconcentration levels.Note: The reagent, calibrator, and quality control material are all packagedseparately. |
|---|---|
| Intended Use /Indications forUse | Elecsys proBNP II: Immunoassay for the in vitro quantitative determinationof N-terminal pro-Brain natriuretic peptide in human serum and plasma.Elecsys proBNP II assay is used as an aid in the diagnosis of individualssuspected of having congestive heart failure. The test is further indicated forthe risk stratification of patients with acute coronary syndrome and congestiveheart failure. The test may also serve as an aid in the assessment of increasedrisk of cardiovascular events and mortality in patients at risk for heart failurewho have stable coronary artery disease.The electrochemiluminescence immunoassay "ECLIA" is intended for use onElecsys and cobas e immunoassay analyzers.The Elecsys PreciControl Cardiac II is used for quality control of specifiedimmunoassays on the Elecsys and cobas e immunoassay analyzers.The Elecsys proBNP II CalSet is used for calibrating the quantitativeElecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers. |
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| Substantialequivalence | The Elecsys proBNP II Test System is substantially equivalent to otherdevices legally marketed in the United States.1.) Elecsys proBNP II Immunoassay is equivalent to the Elecsys proBNPImmunoassay (K051382). |
|---|---|
| 2.) Elecsys PreciControl Cardiac II is equivalent to Elecsys PreciControlCardiac (K032089).3.) Elecsys proBNP II CalSet is equivalent to Elecsys proBNP CalSet(K022516). |
| Device | The following table compares the Elecsys proBNP II test system with the |
|---|---|
| Comparison - | predicate device (K051382). |
| Immunoassay |
| Immunoassay | ||
|---|---|---|
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay(K051382)Predicate |
| Intended Use /Indication for Use | Immunoassay for the in vitroquantitative determination of N-terminal pro-Brain □atriureticpeptide in human serum andplasma. The Elecsys proBNP assayis used as an aid in the diagnosis ofindividuals suspected of havingcongestive heart failure. The test isfurther indicated for the riskstratification of patients with acutecoronary syndrome and congestiveheart failure. The test may alsoserve as an aid in the assessment ofincreased risk of cardiovascularevents and mortality in patients atrisk for heart failure who havestable coronary artery disease.The electrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on Elecsys and cobas eimmunoassay analyzers. | SameThe electrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on the Elecsys 1010/2010and MODULAR ANALYTICSE170 (Elecsys module)immunoassay analyzers. |
| Immunoassay | ||
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay(K051382)Predicate |
| Analyzer Platforms | Elecsys 1010Elecsys 2010 / cobas e 411MODULAR ANALYTICS E170(Elecsys module) / cobas e 601 | Elecsys 1010Elecsys 2010MODULAR ANALYTICS E170(Elecsys module) |
| Assay Protocol | Sandwich Principle | Same |
| Detection Protocol | Electrochemiluminescent | Same |
| Traceability /Standardization | Standardized against the ElecsysproBNP assay. | Reference standard - purifiedsynthetic NT-proBNP (1-76) inequine serum matrix |
| Calibration Interval | E170/E2010/ cobas e analyzers• After 1 month when using thesame reagent lot• After 7 days when using thesame reagent kitE1010• With every reagent kit• After 7 days (20-25°C)• After 3 days (25-32°C) | E170/E2010• After 1 month (28 days) whenusing the same reagent lot• After 7 days when using thesame reagent kitE1010• With every reagent kit• After 7 days (20-25°C)• After 3 days (25-32°C) |
| Sample Type | Human serum and plasma | Same |
| Reagent Stability | Unopened• Up to stated expiration datestored at 2-8°COpened• 12 weeks at 2-8°• 8 weeks on E170/cobas e601• 8 weeks on E2010/ cobas e411• 4 weeks on E1010 (20-25°ambient temp, up to 20hours opened in total) | Unopened• Up to stated expiration datestored at 2-8°COpened• 12 weeks at 2-8°• 8 weeks on E170• 8 weeks on E2010• 4 weeks on E1010 (20-25°ambient temp, up to 20hours opened in total) |
| Calibrator | Elecsys proBNP II CalSet | Elecsys proBNP CalSet |
| Controls | Elecsys PreciControl Cardiac II | Elecsys PreciControl Cardiac |
| Result Interpretation | 125 pg/ml for patients younger than75 years and 450 pg/ml for patients75 years and older | Same |
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay(K051382)Predicate |
| Instrument | Elecsys 1010, Elecsys 2010, cobase 411, cobas e 601, andMODULAR analytics E170 familyof analyzers | Elecsys 1010Elecsys 2010MODULAR ANALYTICS E170(Elecsys module) |
| Measuring Range | 5-35,000 pg/mL | Same |
| Precision | E170 and cobas e601 – Within run | E170 - Within run |
| 1.9% CV @ 64 pg/mL | 0.9% CV @ 474 pg/mL | |
| 1.5% CV @ 124 pg/mL | 1.1% CV @ 8005 pg/mL | |
| 1.3% CV @ 14142 pg/mL | 0.9% CV @ 13682 pg/mL | |
| 1.8% CV @ 77.0 pg/mL | 0.8% CV @ 208 pg/mL | |
| 1.2% CV @ 2105 pg/mL | 3.0% CV @ 3786 pg/mL | |
| E170 and cobas e601 - Total | E170 - Total | |
| 3.1% CV @ 46 pg/mL | 5.8% CV @ 494 pg/mL | |
| 2.7% CV @ 125 pg/mL | 4.1% CV @ 7827 pg/mL | |
| 1.7% CV @ 32930 pg/mL | 3.7% CV @ 13143 pg/mL | |
| 2.7% CV @ 77.0 pg/mL | 4.5% CV @ 200 pg/mL | |
| 2.7% CV @ 2170 pg/mL | 3.6% CV @ 4002 pg/mL | |
| E1010/2010 and cobas e 411 –Within run | E1010/2010 - Within run | |
| 4.2%CV @ 44.0 pg/mL | 2.7% CV @ 175 pg/mL | |
| 2.4%CV @ 126 pg/mL | 2.4% CV @ 355 pg/mL | |
| 1.3%CV @ 2410 pg/mL | 1.9% CV @ 1068 pg/mL | |
| 2.7%CV @ 33606 pg/mL | 1.8% CV @ 4962 pg/mL | |
| 2.58% CV @ 82.0 pg/mL | 1.8% CV @ 434 pg/mL | |
| 1.18% CV @ 2318 pg/mL | 1.8% CV @ 6781 pg/mL | |
| E1010/2010 and cobas e411 –Total | E1010/2010 - Total | |
| 4.6%CV @ 44.0 pg/mL | 3.2% CV @ 175 pg/mL | |
| 2.6%CV @ 126 pg/mL | 2.9% CV @ 355 pg/mL | |
| 1.8%CV @ 2410 pg/mL | 2.6% CV @ 1068 pg/mL | |
| 3.8%CV @ 33606 pg/mL | 2.3% CV @ 4962 pg/mL | |
| 2.8% CV @ 82.0 pg/mL | 2.4% CV @ 434 pg/mL | |
| 1.6% CV @ 2318 pg/mL | 2.2% CV @ 6781 pg/mL | |
| Immunoassay, continued | ||
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay(K051382)Predicate |
| Hook Effect | No effect up to 300,000 pg/mL | same |
| Analytical Sensitivity | 5 pg/mL | same |
| Method Comparison | Elecsys proBNP II (y) compared toElecsys proBNP (x): linearregression (y= 1.0x – 21.74);Passing/Bablok (y= 0.98x – 0.31) | n.a. |
| Limit of Blank /Analytical Sensitivity | 1.72 pg/mL | 5 pg/mL |
| Limit of Detection | 2.83 pg/mL | |
| Limit of Quantitation(as determined by afunctional sensitivitystudy) | 50 pg/mL | < 50 pg/mL |
| Limitations | No interference from bilirubin if less than 25 mg/dL No interference from hemoglobin if less than 1.0 g/dL No interference from intralipids if less than 1500 mg/dL No interference with biotin if less than 30 ng/mL No interference from rheumatoid factor up to 1500 IU/mL In patients receiving high biotin doses > 5 mg/day, sample should not be taken until 8 hours after administration. Rare occurrence of interference from high titers of anti-streptavidin and ruthenium Use in conjunction with patient medical history, clinical exam and other findings | No interference from bilirubin if less than 35 mg/dL No interference from hemoglobin if less than 1.4 g/dL No interference from triglycerides if less than 4000 mg/dL No interference with biotin if less than 30 ng/mL No interference from rheumatoid factor up to 1500 IU/mL In patients receiving high biotin doses > 5 mg/day, sample should not be taken until 8 hours after administration. Rare occurrence of interference from high titers of anti-streptavidin and ruthenium Use in conjunction with patient medical history, clinical exam and other findings |
.
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Device The following table compares the Elecsys proBNP II test system with the Comparison predicate device (K032089). PreciControl Cardiac II
| PreciControl Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Cardiac II | Elecsys PreciControl Cardiac(K032089) Predicate |
| Intended Use | Used for quality control ofspecified immunoassays on theElecsys and cobas e immunoassayanalyzers. | Used for quality control of theElecsys CK-MB, Digoxin,Myoglobin, and NT-proBNPimmunoassays on the Elecsysimmunoassay systems. |
| Levels | Two | same |
| Format | Lyophilized, based on humanserum | same |
| Analyte Concentration | CK-MB: approx. 5 and 50 ng/mlDigitoxin: approx. 17 and 38ng/mL (not for use in U.S.)Digoxin: approx. 1.2 and 3 ng/mlMyoglobin: approx. 80 and 1000ng/mlNT-proBNP: approx. 0.15 and 5ng/ml | CK-MB: approx. 5 and 50 ng/mlDigoxin: approx. 1.2 and 3 ng/mlMyoglobin: approx. 80 and 1000ng/mlNT-proBNP: approx. 0.15 and 5ng/ml |
| Stability | Unopened: store at 2 - 8°C up toexpiration dateReconstituted:3 hrs at 20 - 25°C (on analyzer)3 days at 2 - 8°C3 months at -20°C (freeze onlyonce)After thawing -- use only once | same |
| Handling | Dissolve carefully the contents ofone bottle by adding exactly 2.0mL of distilled water and allowstand closed for 15 minutes toreconstitute. Mix carefully,avoiding the formation of foam. | same |
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Device The following table compares the Elecsys proBNP II test system with the Comparison predicate device (K032089). CalSet
| CalSet Comparison | ||
|---|---|---|
| Characteristic | Elecsys proBNP II CalSet | Elecsys proBNP CalSet(K022516) Predicate |
| Intended Use | Used for calibrating thequantitative Elecsys proBNP IIassay on Elecsys and cobas eimmunoassay analyzers. | Used for calibrating thequantitative Elecsys proBNP assayon Elecsys 1010/2010 andMODULAR ANALYTICS E170immunoassay systems. |
| Levels | Two | same |
| Format | Lyophilized, based on equineserum | same |
| Stability | Unopened:• Store at 2 - 8°C until expirationdate.Reconstituted:• 2 – 8°C: 2 weeks• -20°C: 3 months (freeze onlyonce)• On Elecsys 1010/2010 andcobas e411 analyzers at 20 -25°C: up to 5 hours• On MODULAR ANALYTICSE170 and cobas e601analyzers: use only once | Unopened:• Store at 2 - 8°C until expirationdate.Reconstituted:• 2-8°C: 2 weeks• -20°C: 3 months (freeze onlyonce)• On Elecsys 1010/2010analyzers at 20 - 25°C: up to 5hours• On MODULAR ANALYTICSE170: use only once |
| Handling | Dissolve contents of one bottle byadding exactly 1.0 mL of distilledwater and allow to stand closed for15 minutes to reconstitute. Mixcarefully, avoiding the formation offoam. | same |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB - 5 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Inc. c/o Ms. Kay A. Taylor MT (ASCP) Regulatory Affairs Principal 9115 Hague Road PO Box 50457 Indianapolis, IN 46250
K072437 Re:
Trade/Device Name: Elecsys proBNP II Immunoassay Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-Type Natriuretic Peptide Regulatory Class: Class II Product Code: NBC, JJY, JIT Dated: January 29, 2008 Received: January 30, 2008
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use - Elecsys proBNP II Immunoassay
510(k) Number (if known):
Device Name: Elecsys proBNP II Immunoassay
Indication For Use:
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.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072437
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Indication for Use – Elecsys PreciControl Cardiac II
510(k) Number (if known):
Device Name: Elecsys PreciControl Cardiac II
Indication For Use:
The Elecsys PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benenn
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072437
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Indication for Use - Elecsys proBNP II CalSet
510(k) Number (if known):
Device Name: Elecsys proBNP II CalSet
Indication For Use:
The Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072437
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§ 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.”