DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR

K061795 · Dade Behring, Inc. · NBC · Sep 11, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061795
• Device Name: DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: NBC · Clinical Chemistry
• Decision Date: Sep 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. In individuals suspected of having congestive heart failure (CHF), measurements of NTproBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. The NT-proBNP (PBNP) Calibrator is an in vitro diagnostic product intended to be used for calibration of N-terminal pro-brain natriuretic peptide (PBNP) method for the Dimension Vista™ System.

Device Story

Dimension Vista™ PBNP is an in vitro diagnostic immunoassay for quantitative measurement of NT-proBNP in human serum/plasma. Operates on Dimension Vista™ System using Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. Input: patient serum/plasma sample. Process: sample incubated with biotinylated antibody and Chemibeads (coated with antibody specific to NT-proBNP epitope) to form sandwich; Sensibeads (streptavidin-coated with photosensitive dye) added to form bead-aggregated immunocomplex. Illumination at 680 nm generates singlet oxygen, triggering chemiluminescent reaction measured at 612 nm. Signal intensity proportional to NT-proBNP concentration. Used in clinical laboratory settings by trained personnel. Output: quantitative NT-proBNP concentration. Results assist clinicians in diagnosing/assessing CHF severity and risk-stratifying acute coronary syndrome/heart failure patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance characteristics, including sensitivity, specificity, interference testing, and comparative testing against the predicate device.

Technological Characteristics

One-step sandwich chemiluminescent immunoassay using LOCI™ technology. Reagents: two latex bead types (Sensibeads, Chemibeads) and biotinylated polyclonal antibody. Detection: 680 nm excitation, 612 nm emission. Sample volume: 8 µL. Calibration: 30-day interval. Calibrator: frozen liquid synthetic NT-proBNP in bovine albumin matrix.

Indications for Use

Indicated for quantitative measurement of NT-proBNP in human serum/plasma to aid in diagnosis and severity assessment of congestive heart failure (CHF) and risk stratification of acute coronary syndrome and heart failure 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

• Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516)

Submission Summary (Full Text)

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# SEP 1 1 2006

### 510(k) Summary

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

The assigned 510(k) number is: K061795

#### 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

| Manufacturer: | Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714 |
|----------------------|------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714<br>Attn: Pamela A. Jurga<br>Tel: [phone] |
| Date of Preparation: | June 23, 2006 |

#### 2. Device Name / Classification

- Dimension Vista™ PBNP reagent cartridge/ Class II .
- Dimension Vista™ PBNP calibrator/ Class II .

#### 3. Identification of the Predicate Device

- . Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516).
### FDA Guidance Document(s):

- . "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers" - 11/30/2000
#### 4. Device Description(s):

### Method

The PBNP method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated polyclonal antibody fragment which recognize an epitope located in the

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N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NT-proBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NTproBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.

# Calibrator

The PBNP Calibrator is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in a bovine albumin matrix with stabilizers and preservative. The kit consists of eight vials, two each of four levels (A, B, C, and D), 1.0 mL per vial for levels A, C, and D and 1.5 mL per vial for level B. Description of the manufacturing, value assignment and stability testing processes are provided in Section 21.

#### 5. Device Intended Use:

# Method

The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal probrain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. In individuals suspected of having congestive heart failure (CHF), measurements of NTproBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.

# Calibrator

The NT-proBNP (PBNP) Calibrator is an in vitro diagnostic product intended to be used for calibration of N-terminal pro-brain natriuretic peptide (PBNP) method for the Dimension Vista™ System.

#### 6. Medical device to which equivalence is claimed:

# Substantial Equivalence:

These products are substantially equivalent to other B-type natriuretic peptide test systems, such as the Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516).

See examples of the predicate device labeling in Section 12.1.

# Comparison to Predicate Device:

# Method

The proposed Dade Behring Dimension Vista™ PBNP method and the predicate Roche Diagnostics Elecsys® proBNP immunoassay are both in vitro diagnostic immunoassays intended for the quantitative measurement of N-terminal pro-brain natriuretic peptide in human serum and heparinized plasma. See Section 12.1 for a copy of the predicate labeling. The Dade Behring Dimension Vista™ PBNP Flex® method utilizes the Roche polyclonal (sheep) antibody/antigen set. A summary of the features of the two assays is included in the table below.

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:

| Feature | Dimension Vista® PBNP | Roche Elecsys® proBNP<br>(K032646/K022516) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the <i>in vitro</i> quantitative<br>measurement of N-terminal pro-<br>brain natriuretic peptide in human<br>serum and plasma. In individuals<br>suspected of having congested heart<br>failure (CHF) measurements of NT-<br>proBNP are used as an aid in the<br>diagnosis and assessment of<br>severity. The test is further<br>indicated for the risk stratification<br>of patients with acute coronary<br>syndrome and heart failure. | For the <i>in vitro</i> quantitative<br>determination of N-terminal pro-brain<br>natriuretic peptide in human serum<br>and plasma. The Elecsys proBNP<br>assay is used as an aid in the<br>diagnosis of individuals suspected of<br>having congestive heart failure.<br>The test is further indicated for the<br>risk stratification of patients with<br>acute coronary syndrome and<br>congestive heart failure. |
| Assay Type<br>(detection) | immunoassay<br>(chemiluminescent) | immunoassay<br>(electrochemiluminescent) |
| Reportable Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Roche Diagnostics'<br>polyclonal (sheep) antibody | polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL for patients less than 75<br>years and 450 pg/mL for patients 75<br>years and older | 125 pg/mL for patients less than 75<br>years and 450 pg/mL for patients 75<br>years and older |
| Analytical<br>Sensitivity | ≤ 5 pg/mL | 5 pg/mL |
| Functional<br>Sensitivity | ≤ 30 pg/mL | < 50 pg/mL |
| Analytical<br>Specificity | Natercor® shows no significant<br>cross reactivity, 0 or 125 pg/mL<br>NT-proBNP; sixteen other<br>substances show no significant<br>cross reactivity | Natercor® shows no significant cross<br>reactivity, 300 pg/mL or 3000 pg/mL<br>NT-proBNP; sixteen other substances<br>show no significant cross reactivity |
| Interferences | No significant interference from:<br>bilirubin ,conj. up to 60 mg/dL | No significant interference from:<br>bilirubin up to 35 mg/dL<br>hemoglobin up to 1.4 g/dL |
| | hemoglobin up to 680 mg/dL<br>triglycerides up to 3000 mg/dL<br>rheumatoid factors up to 500 IU/mL | triglycerides up to 4000 mg/dL<br>rheumatoid factors up to 1500 IU/mL |
| Reference | Roche NT-proBNP antibody (1-76) | Roche NT-proBNP antibody (1-76) |
| Hook Effect | No effect up to 400,000 pg/mL | No effect up to 300,000 pg/mL |
| Calibration Interval | 30 days - same reagent lot | 30 days - same reagent lot |
| Sample Volume | 8 uL | 20 uL |

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# Calibrator:

| Feature | Dimension Vista® PBNP | Roche Elecsys® proBNP<br>(K032646/K022516) |
|--------------|---------------------------------------------------------------------------------------------------|--------------------------------------------|
| Intended Use | PBNP method calibration | proBNP method calibration |
| Analyte | Synthetic NT-proBNP | Synthetic NT-proBNP |
| Matrix | Bovine albumin | Equine serum |
| Form | Liquid, frozen | Lyophilized |
| Volume | 8 vials, 2 at each level, 1.0 mL per<br>vial for level A, C and D, 1.5 mL<br>per vial for level B | 1 mL for each level |
| Levels | 4 levels (0, 125, 1500, and 36750<br>pg/mL) | 2 levels (140 and 2700 pg/mL) |

# Proposed Labeling:

See Section 13.1 for a copy of the proposed Dimension Vista™ PBNP Flex® reagent cartridge and PBNP Calibrator labeling.

Note: Section 22 contains an additional set of draft labeling for CLIA categorization purposes.

# Comments on Substantial Equivalence:

### Method

Both the Dade Behring Dimension Vista™ PBNP and the Roche Elecsys® proBNP immunoassays are intended for the quantitative determination of NT-proBNP. Comparative data for human secure and plasma samples demonstrate good analytical and clinical agreement between the r nethods.

### Calibrator

The Dade Behring Dimension Vista™ PBNP calibrator is similar to other calibrator products associated with their assays, such as the Roche Elecsys® proBNP CalSet calibrator.

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Dade Behring Inc. Dimension Vista™ NT-proBNP (PBNP) Method and Calibrator

#### Conclusion:

The Dade Behring Dimension Vista™ PBNP Flex® method and the predicate Roche Elecsys® proBNP immunoassay (K032646) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator product is also equivalent in its design and intended use with its respective assay systems.

Jussek
Randolph L.

Pamela A. Jurga Regulatory Affairs and Compliance Manager June 23, 2006

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered on the image. There is a logo to the left of the text. The logo is a stylized image of a person.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Pamela Jurga Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

SEP 1 1 2006

Re: k061795

> Trade/Device Name: Dimension® Vista™ NT-proBNP (PBNP) Flex® reagent cartridge method Dimension® Vista™ NT-proBNP (PBNP) calibrator Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC, JIT Dated: August 14, 2006 Received: August 15, 2006

Dear Ms. Pamela Jurga:

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 Gutz

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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Dade Behring Inc. Dimension Vista™ NT-proBNP (PBNP) Method and Calibrator 510(k) Premarket Notification

# Indications for Use

40617

# 510(k) Number (if known):

Device Name:

- Dimension® Vista™ NT-proBNP (PBNP) Flex® reagent cartridge method .
- Dimension® Vista™ NT-proBNP (PBNP) calibrator .

#### Indications For Use:

#### Method

The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. In individuals suspected of having congestive heart failure (CHF) measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.

#### Calibrator

The Dimension Vista™ NT-proBNP (PBNP) calibrator is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (PBNP) method on the Dimension Vista™ System.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use - - -(21 CFR 801)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF 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

K061795