(160 days)
Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. The Elecsys proBNP II STAT 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 the cobas e 601 immunoassay analyzer.
The proBNP II Assay is a sandwich immunoassay with two antibodies directed towards epitopes within the N-terminal portion of the proBNP molecule. The capture antibody is biotinylated to react with streptavidin-coated microparticles. The signal antibody is tagged with ruthenium. Both antibodies are monoclonal. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.
Acceptance Criteria and Device Performance Study for Elecsys proBNP II STAT Immunoassay
This document describes the acceptance criteria and the study that demonstrates the Elecsys proBNP II STAT Immunoassay meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys proBNP II STAT Immunoassay are primarily demonstrated by showing substantial equivalence to the predicate device, the Elecsys proBNP II Assay (K072437), with key performance characteristics either matching or falling within acceptable ranges. The primary difference is the faster "STAT" application time and limited instrument platform.
| Feature | Acceptance Criteria (Predicate Device K072437) | Reported Device Performance (Elecsys proBNP II STAT Assay) |
|---|---|---|
| Intended Use/Indications for Use | Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. Aid in diagnosis of individuals suspected of congestive heart failure. Risk stratification of patients with 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. Intended for use on Elecsys and cobas e immunoassay analyzers. | Same, except: Assay name changed to "Elecsys proBNP II STAT assay". Intended for use only on the cobas e 601 immunoassay analyzer. |
| Assay Protocol | Sandwich assay | Same |
| Detection Protocol | Electrochemiluminescent Immunoassay | Same |
| Application Time | 18 Minute | STAT (9 Minute) - This is a key improvement/change. |
| Instrument Platform | Roche Elecsys 2010/cobas e 411 and MODULAR ANALYTICS E170/cobas e 601 | cobas e 601 - Limited to this specific platform. |
| Sample Volume | 15 µL | Same |
| Sample Type | Human serum and plasma treated with K2-EDTA, K3-EDTA, lithium heparin and Na-heparin plasma. | Same |
| Reagents | Sandwich immunoassay with two monoclonal antibodies (biotinylated capture (streptavidin-coated microparticles) and ruthenium-tagged signal) directed towards epitopes within the N-terminal portion of the proBNP molecule. | Same antibodies and same epitopes. |
| Traceability/Standardization | Standardized against the Elecsys proBNP assay (K022516), which was standardized against reference standards by weighing pure synthetic NT-proBNP (1-76 amino acids) into equine serum matrix. | Same. |
| Calibrator | Elecsys proBNP II CalSet (K072437) | Elecsys proBNP II STAT CalSet (different material number, identical stability, value assignment, and matrix). |
| Calibration Interval | Once per reagent lot (fresh reagent, <24h since registration). Renewed calibration recommended: MODULAR ANALYTICS E170, Elecsys 2010 and cobas e analyzers: After 1 month (28 days) when using same reagent lot; After 7 days (when using same reagent kit). Elecsys 1010 analyzer: With every reagent kit; After 7 days (ambient 20-25°C); After 3 days (ambient 25-32°C). | Once per reagent lot (fresh reagent, <24h since registration). Renewed calibration recommended: cobas e 601: After 1 month (28 days) when using same reagent lot; After 7 days (when using same reagent kit). |
| Controls | Elecsys PreciControl Cardiac II (K072437). | Same. |
| Reagent Stability/Storage | Unopened: 2-8°C until expiration. After opening: 2-8°C—12 weeks. On MODULAR ANALYTICS E170 and cobas e 601—8 weeks. On Elecsys2010 and cobas e 411—8 weeks. | Same, but only reported on the cobas e 601. |
| Measuring Range | 5-35,000 pg/mL | Same |
| Precision (cobas e 601 - predicate) | Within-run (Repeatability): 1.9% CV @ 64.0 pg/mL, 1.5% CV @ 124.0 pg/mL, 1.3% CV @ 14142.0 pg/mL, 1.8% CV @ 77.0 pg/mL, 1.2% CV @ 2105.0 pg/mL. Total (Intermediate): 3.1% CV @ 46.0 pg/mL, 2.7% CV @ 125.0 pg/mL, 2.7% CV @ 32805.0 pg/mL, 2.7% CV @ 77.0 pg/mL, 2.7% CV @ 2170.0 pg/mL. | Precision (cobas e 601 - STAT assay)Within-run (Repeatability): 2.4% CV @ 130.0 pg/mL, 2.2% CV @ 4942.0 pg/mL, 3.5% CV @ 59.0 pg/mL, 2.0% CV @ 142.0 pg/mL, 1.8% CV @ 522.0 pg/mL, 1.9% CV @ 934.5 pg/mL, 2.0% CV @ 6552.0 pg/mL, 2.9% CV @ 30,870.0 pg/mL. Total (Intermediate): 2.5% CV @ 130.0 pg/mL, 2.6% CV @ 4942.0 pg/mL, 3.5% CV @ 59.0 pg/mL, 2.5% CV @ 142.0 pg/mL, 2.0% CV @ 522.0 pg/mL, 2.5% CV @ 934.5 pg/mL, 2.3% CV @ 6552.0 pg/mL, 5.4% CV @ 30,870.0 pg/mL. Performance is comparable or improved across the measuring range, especially considering the STAT nature. |
| Analytical Sensitivity | Limit of Detection (LoD): 5.00 pg/mL. Functional Sensitivity (LoQ): 50.00 pg/mL. (LoB not reported) | Limit of Blank (LoB): 5.00 pg/mL. Limit of Detection (LoD): 5.00 pg/mL. Functional Sensitivity (LoQ): 50.00 pg/mL. This demonstrates equivalent or improved analytical sensitivity. |
| Hook Effect | No high-dose hook effect up to 300,000 pg/mL (300 ng/mL). | Same. |
| Heterophilic Antibody/Interference | Unaffected by: Hemoglobin ≤ 0.1 g/dL, Bilirubin up ≤ 25 mg/dL, Triglycerides ≤ 1,500 mg/dL, Biotin ≤ 30 ng/mL, Rheumatoid factors ≤ 1,500 IU/mL. No interference with 51 commonly used pharmaceuticals. Minimized risk of interference from immunological interactions with rare sera and monoclonal mouse antibodies. Measures taken to minimize interference from high titers of antibodies to streptavidin and ruthenium. | Same. |
| Method Comparison (Correlation between STAT and Predicate) | N/A (this is the study's objective) | Passing/Bablok: Slope 0.992, Intercept -2.141, Tau/r/rho 0.987. Linear Regression: Slope 0.986, Intercept 13.964, r 0.998.Deming Regression: Slope 0.988, Intercept 8.83, rho 1.00.These results demonstrate strong correlation between the two assays, indicating substantial equivalence in measurement. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: n = 120 patient samples were used for the method comparison study.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, based on the context of a 510(k) submission seeking equivalence to a previously approved device, these data are typically generated in controlled laboratory settings (often prospective testing of patient samples) by the manufacturer or authorized agents.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. This device is an immunoassay measuring a biomarker (NT-proBNP) quantitatively. The "ground truth" for the test set values is considered the measurements obtained by the predicate device itself, not an expert consensus on a diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this is a quantitative immunoassay comparison, there is no "adjudication" in the sense of independent expert review of cases. The comparison is statistical, comparing the results of the new device against the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks where human readers' performance is being evaluated, possibly with AI assistance. For a quantitative immunoassay, the performance is assessed by comparing its measurements to a reference method (the predicate device) and evaluating its analytical characteristics (precision, sensitivity, range).
- Effect Size of Human Readers with/without AI assistance: Not applicable.
6. Standalone Performance Study
- Standalone Study: Yes, a standalone performance study was done for the Elecsys proBNP II STAT Assay. The "method comparison" section directly shows the performance of the new device alone against the predicate device on patient samples (n=120) and demonstrates its analytical performance characteristics (precision, analytical sensitivity, measuring range, hook effect, limitations) independently. The core of this 510(k) summary is to demonstrate that the device itself performs equivalently to the predicate to warrant a "substantially equivalent" classification.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the method comparison study was the measurements obtained from the existing, legally marketed predicate device (Elecsys proBNP II Assay, K072437). This is a common approach in 510(k) submissions for in vitro diagnostic (IVD) devices seeking substantial equivalence where a well-established predicate device exists. The predicate device's measured values are treated as the reference standard for comparison.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not explicitly mention a separate "training set" or its size in the context of typical machine learning models. This is an immunoassay, not an AI/ML-based device in the common understanding. The development and optimization of such assays typically involve iterative laboratory testing and refinement of reagents, protocols, and instrument parameters, which could be considered an internal "training" process, but not in the sense of a distinct, labeled dataset for algorithm training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the conventional sense of AI/ML training. The "ground truth" for developing and optimizing the assay itself would be based on established analytical chemistry principles, characterization of assay components (antibodies, calibrators), and performance against known reference materials or other validated laboratory methods. This iterative process leads to the final assay formulation and protocol, which is then formally validated using the test set described above against the predicate.
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K0926649
Appendix | Updated 510(k) Summary
ستر،
FEB - 4 2010
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys proBNP II Assay (K072437) (18 Minute) | Elecsys proBNP II STAT Assay |
| General Assay Features | ||
| IntendedUse/Indicationsfor Use | Immunoassay for the in vitroquantitative determination of N-terminal pro-brain natriuretic peptidein human serum and plasma. TheElecsys proBNP II assay is used as anaid in the diagnosis of individualssuspected of having congestive heartfailure. The test is further indicatedfor the risk stratification of patientswith acute coronary syndrome andcongestive heart failure. The test mayalso serve as an aid in the assessmentof increased risk of cardiovascularevents and mortality in patients at riskfor heart failure who have stablecoronary artery disease.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on Elecsys and cobas eimmunoassay analyzers. | Same, except:The assay name is changed:... The Elecsys proBNP II STAT assais used as an aid in the diagnosis...Elecsys instruments are removed:The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on the cobas e 601immunoassay analyzer. |
| AssayProtocol | Sandwich assay | Same |
| DetectionProtocol | ElectrochemiluminescentImmunoassay | Same |
| Application | 18 Minute | STAT (9 Minute) |
| InstrumentPlatform | Roche Elecsys 2010/cobas e 411 andMODULAR ANALYTICSE170/cobas e 601 | cobas e 601 |
| SampleVolume | 15 µL | Same |
| Immunoassay Comparison | ||
| Feature | Predicate Device: Elecsys proBNPII Assay (K072437) (18 Minute) | Elecsys proBNP II STAT Assay |
| General Assay Features | ||
| Sample Type | Human serum and plasma treated withK2-EDTA, K3-EDTA, lithium heparinand Na-heparin plasma. | Same |
| Reagents | The proBNP II Assay is a sandwichimmunoassay with two antibodiesdirected towards epitopes within theN-terminal portion of the proBNPmolecule. The capture antibody isbiotinylated to react with streptavidin-coated microparticles. The signalantibody is tagged with ruthenium.Both antibodies are monoclonal | Same antibodies and same epitopes |
| Traceability | The Elecsys proBNP II assay has beenstandardized against the ElecsysproBNP assay (K022516). This in turnwas standardized against referencestandards by weighing pure syntheticNT-proBNP (1-76 amino acids) intoequine serum matrix. | Same |
| Calibrator | Elecsys proBNP II CalSet (K072437) | Elecsys proBNP II STAT CalSet willhave a different material number toavoid confusion on instrument use.The stability, value assignment andmatrix will be identical. |
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{2}------------------------------------------------
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys proBNPII Assay (K072437) (18 Minute) | Elecsys proBNP II STAT Assay |
| General Assay Features | ||
| CalibrationInterval | Calibration must be performed onceper reagent lot using fresh reagent(i.e. not more than 24 hours since thereagent kit was registered on theanalyzer). Renewed calibration isrecommended as follows:MODULAR ANALYTICS E170,Elecsys 2010 and cobas e analyzers:After 1 month (28 days) whenusing the same reagent lotAfter 7 days (when using thesame reagent kit on theanalyzer)Elecsys 1010 analyzer:With every reagent kitAfter 7 days (ambienttemperature 20-25 °C)After 3 days (ambienttemperature 25-32 °C) | Calibration must be performed onceper reagent lot using fresh reagent (i.e.not more than 24 hours since thereagent kit was registered on theanalyzer). Renewed calibration isrecommended as follows:cobas e 601:After 1 month (28 days) whenusing the same reagent lotAfter 7 days (when using thesame reagent kit on theanalyzer) |
| Controls | Elecsys PreciControl Cardiac II(K072437) | Same |
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Premarket Notification, 510(k) for Elecsys proBNP II
STAT Assay, Continued
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys proBNPII Assay (K072437) (18 Minute) | Elecsys proBNP II STAT Assay |
| General assay features | ||
| Traceability /Standardization | This method has been standardizedagainst the Elecsys proBNP assay.This in turn was standardized againstreference standards by weighing puresynthetic NT-proBNP (1-76) into anequine serum matrix. | Same |
| ReagentStability/Storage | Store at 2-8 °C. Store the ElecsysproBNP II reagent kit upright in orderto ensure complete availability of themicroparticles during automaticmixing prior to use.Stability:Unopened at 2-8 °C—up to the statedexpiration dateAfter opening at 2-8 °C—12 weeksOn MODULAR ANALYTICS E170and cobas e 601—8 weeksOn Elecsys2010 and cobas e 411—8weeks | Same, but only reported on the cobase 601. |
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Premarket Notification, 510(k) for Elecsys proBNP II
STAT Assay, Continued
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys proBNPII Assay (K072437) (18 Minute) | Elecsys proBNP II STAT Assay |
| Labeled Performance Characteristics | ||
| MeasuringRange | 5-35,000 pg/mL | Same |
| Precision | Elecsys 1010/2010 and cobas e411 analyzersWithin-run (Repeatability)4.2% CV @ 44.0 pg/mL2.4% CV @ 126.0 pg/mL1.3% CV @ 2410.0pg/mL2.7% CV @ 33606.0 pg/mL2.6% CV @ 82.0 pg/mL1.2% CV @ 2318.0 pg/mLTotal (Intermediate)4.6% CV @ 44.0 pg/mL2.6% CV @ 126.0 pg/mL1.8% CV @ 2410.0pg/mL3.8% CV @ 33606.0 pg/mL2.8% CV @ 82.0 pg/mL1.6% CV @ 2318.0 pg/mLMODULAR ANALYTICS E170 and cobase601:Within-run (Repeatability)1.9% CV @ 64.0 pg/mL1.5% CV @ 124.0 pg/mL1.3% CV @ 14142.0 pg/mL1.8% CV @ 77.0 pg/mL1.2% CV @ 2105.0 pg/mLTotal (Intermediate)3.1% CV @ 46.0 pg/mL2.7% CV @ 125.0 pg/mL2.7% CV @ 32805.0 pg/mL2.7% CV @ 77.0 pg/mL2.7% CV @ 2170.0 pg/mL | cobas e 601:Within-run (Repeatability)2.4% CV @ 130.0 pg/mL2.2% CV @ 4942.0 pg/mL3.5% CV @ 59.0 pg/mL2.0% CV @ 142.0 pg/mL1.8% CV @ 522.0 pg/mL1.9% CV @ 934.5 pg/mL2.0% CV @ 6552.0 pg/mL2.9% CV @ 30,870.0 pg/mLTotal (Intermediate)2.5% CV @ 130.0 pg/mL2.6% CV @ 4942.0 pg/mL3.5% CV @ 59.0 pg/mL2.5% CV @ 142.0 pg/mL2.0% CV @ 522.0 pg/mL2.5% CV @ 934.5 pg/mL2.3% CV @ 6552.0 pg/mL5.4% CV @ 30,870.0 pg/mL |
| Immunoassay Comparison | ||
| Predicate Device: Elecsys proBNPII Assay (K072437) (18 Minute) | Elecsys proBNP II STAT Assay | |
| Feature | Labeled Performance Characteristics | |
| AnalyticalSensitivity | Limit of Blank (LoB) not reportedLimit of Detection (LoD) 5.00 pg/mLLimit of Quantitation (LoQ)Functional Sensitivity: 50.00 pg/mL | Limit of Blank (LoB): 5.00 pg/mLLimit of Detection (LoD): 5.00 pg/mLLimit of Quantitation (LoQ)Functional Sensitivity: 50.00 pg/mL |
| Hook Effect | There is no high-dose hook effect atproBNP concentrations up to 300,000pg/mL (300 ng/mL). | Same |
| Limitations | The assay is unaffected by:• Hemoglobin ≤ 0.1 g/dL• Bilirubin up ≤ 25 mg/dL• Triglycerides ≤ 1,500 mg/dL• Biotin ≤ 30 ng/mL• Rheumatoid factors ≤ 1,500 IU/mLIn vitro tests were performed on 51commonly used pharmaceuticals. Nointerference with the assay was found.• The risk of interference from potentialimmunological interactions betweentest components and rare sera has beenminimized by the inclusion of suitableadditives.• As with all tests containing monoclonalmouse antibodies, erroneous findingsmay be obtained from samples takenfrom patients who have been treatedwith monoclonal mouse antibodies orhave received them for diagnosticpurposes.• In rare cases, interference due toextremely high titers of antibodies tostreptavidin and ruthenium can occur.The test contains additives whichminimize these effects.• For diagnostic purposes, the resultsshould always be assessed inconjunction with the patient's medicalhistory, clinical examination and otherfindings | Same |
/
Continued on next page
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Premarket Notification, 510(k) for Elecsys proBNP II
STAT Assay, Continued
{6}------------------------------------------------
| Immunoassay Comparison | ||||
|---|---|---|---|---|
| Feature | Predicate Device: Elecsys proBNP II Assay (K072437) (18 Minute) | Elecsys proBNP II-STAT Assay | ||
| Labeled Performance Characteristics | ||||
| Method Comparison | Both assays run on the cobas e 601 | |||
| n = 120Min = 5.10 pg/mLMax = 30,583 pg/mL | ||||
| Passing/Bablok | Linear Regression | Deming Regression | ||
| Slope | 0.992 | 0.986 | 0.988 | |
| Intercept | -2.141 | 13.964 | 8.83 | |
| Tau/r/rho | 0.987 | 0.998 | 1.00 |
{7}------------------------------------------------
| CalSet Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys proBNP II CalSet (K072437) | Elecsys proBNP II STAT CalSet |
| Labeled Performance Characteristics | ||
| Intended Use | Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on Elecsys and cobas e immunoassay analyzers. | Elecsys proBNP II STAT CalSet is used for calibrating the quantitative Elecsys proBNP II STAT assay on the cobas e 601 immunoassay analyzer. |
| Levels | Two | Same |
| Format | Lyophilized equine serum | Same |
| AnalyteConcentration | Cal 1: ~140 pg/mLCal 2: ~2,700 pg/mL | Same |
| Handling | Dissolve carefully the contents of one bottle by adding exactly 1.0 mL of distilled water and allow to stand closed for 15 minutes to reconstitute. Mix carefully avoiding the formation of foam. Transfer the reconstituted calibrator into the empty, labeled snap-cap bottles supplied. | Same |
| Stability | Unopened:• Store at 2 – 8°C until expiration date.Reconstituted:• 2 – 8°C: 2 weeks• -20°C: 3 months (freeze only once)• On Elecsys 1010/2010 and cobas e411 analyzers at 20 – 25°C: up to 5 hours• On MODULAR ANALYTICS E170 and cobas e601 analyzers: use only once | Unopened:• Store at 2 – 8°C until expiration date.Reconstituted:• 2 – 8°C: 2 weeks• -20°C: 3 months (freeze only once)• On the analyzer: use only once |
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Roche Diagnostics Corporation requests that the FDA not disclose the nature Confidentiality or existence of the premarket notification until the substantial equivalence decision has been reached.
Closing
We trust that the information provided in this Premarket Notification [Special 510(k)] will support a determination of substantial equivalence for the Elecsys proBNP II STAT Immunoassay.
If you should have questions or require further information, please do not hesitate to contact me.
- Phone: (317) 521-3338
- · FAX: (317) 521-2324
- · jane.phillips(@roche.com
Sincerely,
Jane Phillips, PhD Regulatory Affairs Principal US Regulatory Submissions Roche Diagnostics Corporation
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
FEB - 4 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics Corp. c/o Dr. Jane Phillips, Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250
Re: K092649 Trade Name: Elecsys proBNP II STAT Immunoassay, Elecsys proBNP II STAT CalSet Regulation Number: 21 CFR §862.1117 Regulation Name: B-type Natriuretic Peptide Test System Regulatory Class: Class II Product Codes: NBC, JIT Dated: January 4, 2010 Received: January 5, 2010
Dear Dr. Phillips:
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); medical device reporting (reporting of medical device-related adverse events) (21
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. 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 Form
510(k) Number (if known):
Device Name: Elecsys proBNP II STAT Immunoassay
Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. The Elecsys proBNP II STAT 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 the cobas e 601 immunoassay analyzer.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092649
Page 1 of 2
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Indications for Use Form
510(k) Number (if known):
Device Name: Elecsys proBNP II STAT CalSet
Elecsys proBNP II STAT CalSet is used for calibrating the quantitative Elecsys proBNP II STAT assay on the cobas e 601 immunoassay analyzer.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092649
· Page 2 of 2
§ 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.”