ELECSYS PROBNP IMMUNOASSAY

K022516 · Roche Diagnostics Corp. · NBC · Nov 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022516
• Device Name: ELECSYS PROBNP IMMUNOASSAY
• Applicant: Roche Diagnostics Corp.
• Product Code: NBC · Clinical Chemistry
• Decision Date: Nov 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

For the quantitative determination of N-terminal pro-Brain natriuretic peptide. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Device Story

Elecsys proBNP Immunoassay measures N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human serum or plasma samples. Device utilizes electrochemiluminescence immunoassay (ECLIA) technology on Roche Elecsys family of analyzers (E1010, E2010, E170). Clinicians use quantitative results as an aid in diagnosing congestive heart failure. System provides measuring range of 5-35,000 pg/mL. Results are interpreted alongside patient medical history, clinical examination, and other laboratory findings to support clinical decision-making. Benefits include improved diagnostic assessment for patients suspected of heart failure.

Clinical Evidence

Bench testing only. Performance characteristics evaluated include analytical sensitivity (5 pg/mL), measuring range (5-35,000 pg/mL), precision (within-run 0.8-2.7% CV; total 2.2-5.8% CV), and interference testing (bilirubin, hemoglobin, triglycerides, biotin, rheumatoid factor). No high-dose hook effect observed up to 300,000 pg/mL. Comparison to predicate device provided for assay protocol, calibration, and stability.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Analyte: NT-proBNP. Sample matrix: human serum/plasma. Instrumentation: Elecsys 1010, 2010, and E170 MODULAR Analytics. Measuring range: 5-35,000 pg/mL. Calibration: Elecsys proBNP CalSet. Controls: Elecsys PreciControl proBNP. Connectivity: Integrated with Roche Elecsys analyzer family.

Indications for Use

Indicated for in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma as an aid in the diagnosis of individuals suspected of having congestive heart failure.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Biosite Triage BNP Test (K003475)

Submission Summary (Full Text)

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Roche Diagnostic Corporations 11/12/02

K022516- Elecsys ProBNP

## 510(k) Summary

NOV 1 9 2002

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 521 - 3544<br><br>Contact Person: Kay A. Taylor<br><br>Date Prepared: September 12, 2002 |
| Device Name | Proprietary name: Elecsys® proBNP Immunoassay<br><br>Common name: proBNP test<br><br>Classification name: Test, Natriuretic Peptide |
| Device<br>Description | A device for the measurement of human proBNP in serum or plasma. |
| Intended use | For the quantitative determination of N-terminal pro-Brain natriuretic peptide. |
| Indications for<br>Use | An aid in the diagnosis of individuals suspected of having congestive heart<br>failure. |

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Roche Diagnostic Corporations 11/12/02

#### 510(k) Summary, Continued

The Elecsys proBNP Immunoassay is substantially equivalent to other Substantial devices legally marketed in the United States. We claim equivalence to the equivalence Biosite Triage BNP Test cleared under K003475. Both products are intended for use in the quantitative determination of brain natriuretic peptides.

The following table compares the Roche Elecsys proBNP Immunoassay with Substantial equivalence the predicate device. comparison

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| Feature | Elecsys proBNP<br>Immunoassay | Biosite Triage BNP Test<br>(predicate) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | For the quantitative<br>determination of N-terminal<br>pro-Brain natriuretic peptide. | Measurement of B-Type<br>Natriuretic Peptide (BNP). |
| Indication for Use | An aid in the diagnosis of<br>individuals suspected of<br>having congestive heart<br>failure. | An aid in the diagnosis of<br>congestive heart failure in<br>patients age 55 and older |
| Assay Protocol | Electrochemiluminescent<br>immunoassay | Fluorescence Immunoassay |
| Traceability / Standardization | Reference standard - purified<br>synthetic NTG-proBNP (1-<br>76) in human serum matrix | Purified BNP preparation<br>based on mass of analyte<br>present in EDTA plasma |
| Calibration Interval | E170/E2010<br>After 1 month when using<br>the same reagent lot After 7 days when using<br>the same reagent kit<br>E1010 With every reagent kit After 7 days (20-25°C) After 3 days (25-32°C) | Each kit |
| Sample Type | Human serum and plasma | Human whole blood and<br>EDTA plasma |
| Calibrator | Elecsys proBNP CalSet | Electronic code chip |
| Controls | Elecsys PreciControl proBNP | Triage® BNP Controls |

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# 510(k) Summary, Continued, Continued

| Feature | Elecsys proBNP<br>Immunoassay | Biosite Triage BNP Test<br>(predicate) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent Stability | Unopened<br>• Up to stated expiration<br>date stored at 2-8°C<br>Opened<br>• 12 weeks at 2-8°<br>• 8 weeks on E170<br>• 8 weeks on E2010<br>• 4 weeks on E1010 (20-25°<br>ambient temp - up to 20<br>hours opened in total) | • Up to stated expiration<br>date when stored at 2-8°C.<br>• 14 days at ambient<br>temperature |
| Expected Values | • Age and sex-related<br>descriptive statistics<br>provided<br>• Cut-offs of 125 pg/ml for<br>patients younger than 75<br>years and 450 pg/ml for<br>patients 75 years and<br>older are recommended. | • Age and sex-related<br>descriptive statistics<br>provided<br>• Cut-off 100 pg/mL<br>recommended |
| Instrument | Elecsys family of analyzers<br>(Elecsys 1010, Elecsys 2010<br>and Elecsys E170<br>MODULAR Analytics<br>Immunoassay Analyzers) | Triage® Meter |
| Measuring Range | 5-35,000 pg/mL | 5-1300 pg/mL |
| Feature | Elecsys proBNP Immunoassay | Biosite Triage BNP Test<br>(predicate) |
| Precision | E170<br>Within-run 0.8-1.1 %CV from 208-13,682 pg/mL Total 3.6-5.8% CV from 200-13143 pg/mL<br>E101/2010 Within-run 1.8-2.7 %CV from 175-4962 pg/mL Total 2.2-3.2 %CV from 175-4962 pg/mL | Average within-run 9.4-15.2 %CV from 28.8-1080.4 pg/mL Average total 10.1-16.2 %CV |
| Hook Effect | No high dose hook effect up to<br>300,000 pg/mL | NA |
| Analytical<br>sensitivity (LDL) | 5 pg/mL | 5 pg/mL |
| Limitations/Warnings/Precautions | No interference from bilirubin up to 35 mg/dL No interference from hemoglobin up to 1.4 g/dL No interference from triglycerides up to 4000 mg/dL No interference with biotin up to 30 ng/mL No interference from rheumatoid factor up to 1500 IU/mL In patients receiving high biotin doses > 5 mg/dL, 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 up to 20 mg/dL. No interference from hemoglobin up to 10000 mg/dL<br>Severely hemolyzed specimens should be avoided. No interference from triglycerides up to 1000 mg/dL No interference from cholesterol up to 1000 mg/dL Blood concentrations of natriuretic peptides may be elevated in patients with acute myocardial infarction, patients that are candidates for renal dialysis, and patients that have undergone renal dialysis Results should be evaluated in the context of all the clinical and laboratory data available |

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Roche Diagnostic Corporations 11/12/02

100 - 100 - 100 -

### 510(k) Summary, Continued

The performance characteristics of the Elecsys proBNP Immunoassay and the Substantial equivalence predicate device are compared in the table below. performance characteristics

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kay A. Taylor Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

#### NOV 1 9 200

Re: k022516

> Trade/Device Name: Elecsys® proBNP Immunoassay Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT; JJX Dated: October 23, 2002 Received: October 24, 2002

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.

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Page 2 -

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 (OS) regulation (21 CFR Part 820). 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel H. L.

Steven 1. Gutman, M.D., M.B.A. Director

Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

k 022

510(k) Number (if known): Nes

Device Name:

Elecsys® proBNP Immunoassay

Indications For Use:

Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Cooper

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K022516