ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

K033606 · Axis-Shield Diagnostics, Ltd. · NBC · Jan 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033606
• Device Name: ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
• Applicant: Axis-Shield Diagnostics, Ltd.
• Product Code: NBC · Clinical Chemistry
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

The quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

Device Story

Device is an automated Microparticle Enzyme Immunoassay (MEIA) for quantitative BNP measurement in human EDTA plasma. Operates on Abbott AxSYM System; utilizes mouse monoclonal anti-BNP coated microparticles and alkaline phosphatase-labeled conjugate. Sample and reagents are pipetted into reaction vessels; antigen-antibody complexes form on microparticles; complexes bind to glass fiber matrix in MEIA cell. After washing, substrate 4-Methylumbelliferyl Phosphate is added; alkaline phosphatase catalyzes conversion to fluorescent 4-Methylumbelliferone. Fluorescence measured by MEIA optical assembly. Used in clinical laboratory settings by trained personnel. Output is quantitative BNP concentration (pg/mL). Clinicians use results as an aid in heart failure diagnosis and severity assessment (NYHA classification correlation).

Clinical Evidence

Clinical performance evaluated in 693 heart failure patients and 890 non-heart failure individuals. AUC for heart failure diagnosis is 0.90 (95% CI 0.86-0.92). At 100 pg/mL threshold, clinical sensitivity is 74.2% and specificity is 91.5%. Analytical performance includes precision (total CV 6.5-9.4%), linearity (100% ± 10% recovery), and analytical sensitivity (≤ 15 pg/mL). No significant cross-reactivity with ANP, CNP, or NT-proBNP.

Technological Characteristics

Microparticle Enzyme Immunoassay (MEIA). Reagents: mouse monoclonal anti-BNP coated microparticles, alkaline phosphatase conjugate, TRIS buffer. Detection: fluorescence of 4-Methylumbelliferone. Standards: NCCLS EP 5-A (precision), EP 9-A (method comparison), EP 7-A (interference). Automated system (Abbott AxSYM).

Indications for Use

Indicated for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma to aid in the diagnosis and assessment of heart failure severity.

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

• Triage® B-Type Natriuretic Peptide (BNP) test (K021317)

Submission Summary (Full Text)

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## Axis-Shield Diagnostics Ltd 28th Jan 2004

## K033606 - AxSYM®BNP Page 1 of 2

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## 510(k) Summary

#### Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

#### Submitter name, address, contact

Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA Scotland, UK Tel : [phone] Contact Person: Judith Finlayson Date Prepared : January 28, 2004

#### Device Name

| Proprietary Name: | Abbott AxSYM ® B-Type Natriuretic Peptide (BNP)<br>Microparticle Enzyme Immunoassay (MEIA) test |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common name: | BNP test |
| Classification name: | Test, Natriuretic Peptide |

#### Device Description

A device for the measurement of human B-Type Natriuretic Peptide (BNP) in EDTA plasma.

#### Intended Use

The quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

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## 510(k) Summary

#### Substantial equivalence

The AxSYM BNP immunoassay is substantially equivalent to the Biosite Triage BNP Test cleared under K021317. Both products are intended for use in the quantitative determination of B-type natriuretic peptide.

#### Substantial equivalence - comparison

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The following information as presented in the Premarket Notification [510(k)] for AxSYM® BNP constitutes data supporting a substantially equivalent determination.

AxSYM BNP. is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of BNP in human EDTA plasma. AxSYM BNP is calibrated with AxSYM BNP Standard Calibrators. AxSYM BNP Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM system.

Substantial equivalence has been demonstrated between the AxSYM BNP assay and the Biosite Triage® BNP test device. The intended use of both BNP assays is for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. BNP values are used as an aid to the diagnosis assessment of severity of heart failure. Both assays are immunoassays that use antibodies specific for BNP. A Passing Bablok regression analysis between these two assays using 313 specimens with BNP values ranging from 0 to 3426 pg/mL, yielded a correlation coefficient of 0.956, a slope of 1.12 (95% Confidence Interval of 1.08 to 1.18) and a y-axis intercept of -8 (95% Confidence Interval of -6 to -9). Using a decision threshold of 100pg/mL for both tests, the concordance between the two assays was 91.4% (95% Confidence Interval of 87.7% to 94.2%).

In conclusion, these data demonstrate that the AxSYM BNP assay is as safe and effective as, and is substantially equivalent to the Biosite Triage BNP test device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 3 0 2004

Judith Finlayson, Ph.D. Regulatory Affairs Manager Axis-Shield Diagnostics The Technology Park Dundee DD2 1XA Scotland, UK

Re: k033606

Trade/Device Name: Abbott AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT; JJX Dated: November 13, 2003 Received: November 17, 2003

Dear Dr. Finlayson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease of the enactment date of the Medical Device Amendments, or to commerce prior to rial) 2011-11-17 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 r ou mays arovisions of the Act include requirements for annual registration, listing of general concern 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 If your device is elasoned (soo as or of ols. Existing major regulations affecting your device can may or subject to bank now in the may of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA be found in The Frid Level and our eming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Teass of actived that I Drivination that your device complies with other requirements of the Act that I DT has made a sond regulations administered by other Federal agencies. You must or any I oderal sthates and sequirements, including, but not limited to: registration and listing (21

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#### Page 2

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). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, 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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#### INTENDED USE 4.

# 510 (k) number K03 360 مكاما3

### Device Name

Abbott AxSYM ® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA)

#### Indications for Use

AxSYM ® BNP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

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Concurrence of XDRH, Office of Device Evaluation (ODF)

Carol C Benson for Jean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k03 3606

Prescription Use ................................... OR
Per 21 CFR 801.109

Over-the-Counter Use

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