ARCHITECT BNP ASSAY, MODEL 8K28

K060964 · Fujirebio Diagnostics,Inc. · NBC · May 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060964
• Device Name: ARCHITECT BNP ASSAY, MODEL 8K28
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: NBC · Clinical Chemistry
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure. The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information. The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

Device Story

ARCHITECT BNP assay is a two-step chemiluminescent microparticle immunoassay (CMIA) for quantitative BNP measurement in human EDTA plasma. Input: patient EDTA plasma sample. Process: sample incubated with anti-BNP coated paramagnetic microparticles; BNP binds to particles; anti-BNP acridinium-labeled conjugate added; pre-trigger and trigger solutions added to induce chemiluminescence. Output: relative light units (RLUs) measured by ARCHITECT i System optics; RLU intensity directly proportional to BNP concentration. Used in clinical and hospital laboratories by trained personnel. Healthcare providers use quantitative BNP results to assist in diagnosing and assessing heart failure severity. Benefits include standardized, automated laboratory assessment of cardiac biomarkers.

Clinical Evidence

Method comparison study per NCCLS EP9-A2. N=171 EDTA plasma samples (128 heart failure, 43 non-heart failure). Comparison between ARCHITECT BNP and AxSYM BNP. Passing-Bablok regression: correlation coefficient 0.96; intercept -38.32 (95% CI: -48.26 to -28.50); slope 1.03 (95% CI: 0.98 to 1.09). Sample range 0-3702 pg/mL.

Technological Characteristics

CMIA technology; paramagnetic microparticles; anti-BNP (106.3) mouse monoclonal capture antibody; anti-BNP (BC203) mouse monoclonal conjugate antibody; chemiluminescent detection; automated on ARCHITECT i System; EDTA plasma specimen; 6-level calibration; 3-level controls.

Indications for Use

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

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

• Abbott AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) (k033606)

Submission Summary (Full Text)

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## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _

MAY 2 5 2006

## Submitter Information

| Address: | Fujirebio Diagnostics, Inc.<br>201 Great Valley Parkway<br>Malvern, PA 19355 | |
|---------------------------|------------------------------------------------------------------------------|--|
| Contact person: | Diana L. Wolaniuk, [phone] | |
| Summary preparation date: | April 4, 2006 | |
| Name of Device | | |
| Trade/Proprietary Name: | ARCHITECT® BNP Assay | |
| Common/Usual Name: | BNP (B-Type Natriuretic Peptide) Test | |

## Predicate Device

Classification Name:

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

Test, Natriuretic Peptide

## Device Description

ARCHITECT BNP assay is a two-step immunoassay for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma using CMIA technology with flexible assay protocols, refereed to as Chemiflex®.

In the first step, sample and anti-BNP coated paramagnetic microparticles are combined. BNP present in the sample bind to the anti-BNP coated microparticles. After washing, anti-BNP acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of BNP in the sample and the RLUs detected by the ARCHITECT i System optics.

For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.

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#### Intended Use

#### Reagent Kit

The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

#### Calibrator Kit

The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

#### Control Kit

The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

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## Statement of Substantial Equivalence

The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

The ARCHITECT BNP Assay kit is substantially equivalent to the AxSYM BNP Assay. Both of the devices are IVD products and are indicated for the quantitative determination of BNP assay values (human B-type natriuretic peptide) and used as an aid in the diagnosis and assessment of severity of heart failure.

A study was performed with guidance from NCCLS Protocol EP9-A2' to compare the ARCHITECT BNP assay to the AxSYM BNP assay. EDTA plasma samples form 171 individuals (128 heart failure patients, 43 non-heart failure individuals) were tested with both assays. These samples were collected from populations of individuals with and without heart failure. The results from the Passing-Bablok2 linear regression analysis is summarized in the following table. *

| ARCHITECT BNP vs. AxSYM BNP | | | | | |
|-----------------------------|------------------|-----|----------------------------|------------------------------|------------------------|
| Regression<br>Method | Specimen<br>Type | N | Correlation<br>Coefficient | Intercept<br>(95% CI) | Slope<br>(95% CI) |
| Passing-<br>Bablok** | EDTA<br>Plasma | 171 | 0.96 | -38.32<br>(-48.26 to -28.50) | 1.03<br>(0.98 to 1.09) |

Sample Range (ARCHITECT): 0-3702 pg/mL Sample Range (AxSYM): 50 - 3103 pg/mL

* Representative data; variables such as differences in sampling size and population may impact the correlation of the assay. Therefore, results in individual laboratories may vary from these data. .

** A linear regression method with no special assumptions regarding the distribution of the samples and measurement errors.

¹ National Committee for Clinical Laboratory Standards. Method comparison and bias estimation using patient samples; Approved Guideline-Second Edition. NCCLS Document EP9-A2, Wayne, PA: NCCLS, 2002.

² Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21(11)709-20.

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A comparison of the features of the ARCHITECT BNP assay device and the AxSYM BNP assay device are as follows:

| | ARCHITECT BNP<br>(Proposed Device) | AxSYM BNP<br>(Predicate Device)<br>K033606 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and<br>Product Code | Class II, NBC | Class II, NBC |
| Principle of Operation | Chemiluminscent Microparticle<br>Immunoassay (CMIA) | Microparticle Enzyme<br>Immunoassay (MEIA) |
| Product Usage | Clinical and Hospitals laboratories | Clinical and Hospitals laboratories |
| Intended Use | The ARCHITECT BNP assay is a<br>chemiluminescent microparticle<br>immunoassay (CMIA) for the<br>quantitative determination of<br>human B-type natriuretic peptide<br>(BNP) in human EDTA plasma on<br>the ARCHITECT i System. BNP<br>values are used as an aid in the<br>diagnosis and assessment of<br>severity of heart failure. | AxSYM BNP is a Microparticle<br>Enzyme Immunoassay (MEIA) for<br>the quantitative determination of<br>human B-type natriuretic peptide<br>(BNP) in human EDTA plasma on<br>the AxSYM System. BNP values<br>are used as an aid in the diagnosis<br>and assessment of severity of<br>heart failure. |
| Type of Specimen | EDTA Plasma | EDTA Plasma |
| Specimen Collection<br>Method | Plastic collection tubes | Plastic collection tubes |
| Capture Antibody | Anti-BNP (106.3) mouse<br>monoclonal | Anti-BNP (106.3) mouse<br>monoclonal |
| Conjugate Antibody | Anti-BNP (BC203) mouse<br>monoclonal | Anti-BNP (BC203) mouse<br>monoclonal |
| Calibrator | 6 levels (0 - 5000 pg/mL) | 6 levels (0 - 4000 pg/mL) |
| Controls | 3 levels (Low = 90 pg/mL,<br>Medium = 500 pg/mL, High =<br>3500 pg/mL) | 3 levels (Low = 100 pg/mL,<br>Medium = 440 pg/mL, High =<br>1500 pg/mL) |
| Interpretation of Results | Calibrator Curve<br>A direct relationship exists<br>between the amount of BNP in the<br>sample and the light detected by<br>the instrument system | Calibrator Curve<br>A direct relationship exists<br>between the amount of BNP in the<br>sample and the light detected by<br>the instrument system |

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Diana L. Wolaniuk Clinical and Regulatory Affairs Specialist Fujirebio Diagnostics, Inc. 201 Great Valley Parkway - Malvern, PA 19355

MAY 2 5 2006

Re: k060964

> Trade/Device Name: ARCHITECT® BNP ARCHITECT BNP Reagent Kit ARCHITECT BNP Calibrator Kit ARCHITECT BNP Control Kit

Regulation Number: 21 CFR§862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class II Product Code: NBC, JIT, JJX Dated: April 5, 2006 Received: April 7, 2006

Dear Ms. Wolaniuk:

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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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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, 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

510(k) Number (if known):

K060964

Device Name: ARCHITECT® BNP

Indications For Use:

## ARCHITECT BNP Reagent Kit

The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

## ARCHITECT BNP Calibrator Kit

The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

## ARCHITECT BNP Control Kit

The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

Prescription Use
(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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

s(k) K060964

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