DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA

K080578 · Siemens Healthcare Diagnostics, Inc. · NBC · May 16, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080578
• Device Name: DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: NBC · Clinical Chemistry
• Decision Date: May 16, 2008
• 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 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. The PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System

Device Story

The Dimension Vista® PBNP assay is a one-step sandwich chemiluminescent immunoassay utilizing LOCI® technology. The system processes human serum or plasma samples using two synthetic bead reagents (Sensibeads and Chemibeads) and a biotinylated monoclonal antibody fragment. The assay forms a particle/NT-proBNP/biotinylated antibody sandwich; subsequent addition of Sensibeads creates a bead-aggregated immunocomplex. Illumination at 680 nm triggers a chemiluminescent reaction measured at 612 nm, with signal intensity directly proportional to NT-proBNP concentration. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and assessing the severity of congestive heart failure and stratifying risk in acute coronary syndrome patients. The system includes a dedicated calibrator (frozen liquid bovine albumin matrix) to ensure measurement accuracy.

Clinical Evidence

Bench testing only. Performance characteristics including analytical sensitivity (≤ 5 pg/mL), functional sensitivity (≤ 30 pg/mL), and interference profiles (bilirubin, hemoglobin, triglycerides) were evaluated. Hook effect was assessed up to 400,000 pg/mL. Comparative testing demonstrated equivalent performance to the predicate device.

Technological Characteristics

Chemiluminescent immunoassay using LOCI® technology. Reagents: two synthetic bead reagents (Sensibeads with streptavidin/photosensitive dye; Chemibeads with antibody/chemiluminescent dye) and biotinylated monoclonal sheep antibody. Sample volume: 8 µL. Measuring range: 5-35,000 pg/mL. Calibration interval: 30 days. Calibrator: frozen liquid, 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 for risk stratification of patients with acute coronary syndrome and 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

• Dimension Vista® PBNP Flex® reagent cartridge (K6423)
• Dimension Vista® PBNP Calibrator (KC676)

Submission Summary (Full Text)

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### 510(k) Summary of Safety and Effectiveness for the Dimension Vista® P-BNP Mono Flex® Reagent Cartridge (K6423A) and Dimension Vista® P-BNP Mono Calibrator (KC676A)

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.

A. 510(k) Number: k080578

MAY 1 6 2008

B. Date of Preparation: February 27, 2008

## C. Proprietary and Established Names:

Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge (K6423A)

Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Calibrator (KC676A)

## D. Applicant:

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Requlatory Affairs and Compliance Manager Office: [phone] Fax: [phone]

## E. Regulatory Information:

Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge (K6423A)

- 1. Regulation section: 21 CFR § 862.1117 B-type natriuretic peptide test system
- 2. Classification: Class II
- 3. Product Code: NBC, Test, Natriuretic Peptide
- 4. Panel: Clinical Chemistry

Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Calibrator (KC676A)

- 1. Requlation section: 21 CFR § 862.1150 Calibrator, Secondary
- 2. Classification: Class II
- 3. Product Code: JIT, Calibrator, Secondary
- 4. Panel: Clinical Chemistry

## F. Predicate Device:

The Dimension Vista® PBNP Flex® reagent cartridge (K6423A) and the Dimension Vista® PBNP Calibrator (KC676A) are substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423) and the Dimension Vista® PBNP Calibrator (KC676) both cleared under K061795.

## G. Device Description:

### Method

The PBNP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and a biotinylated monoclonal antibody fragment which recognize an epitope located in the 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

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with Chemibeads and biotinylated antibody to form a particle/NT-proBNP/biotiny|ated antibody sandwich. Sensibeads then are added and bind to the biotin 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 Nterminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

#### H. Intended 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 PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.

#### I. Substantial Equivalence Information:

The Dimension Vista® PBNP Flex® reagent cartridge (K6423A) and the Dimension Vista® PBNP Calibrator (KC676A) and the predicate devices, the Dimension Vista® PBNP Flex® reagent cartridge (K6423) and the Dimension Vista® PBNP Calibrator (KC676) were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:

#### Method

| Feature | Dimension Vista® PBNP Flex®<br>reagent cartridge (K6423A) | Dimension Vista® PBNP Flex®<br>reagent cartridge (K6423) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The PBNP method is an in vitro<br>diagnostic assay for the quantitative<br>measurement of N-terminal pro-brain<br>natriuretic peptide (NT-proBNP) in<br>human serum and plasma on the<br>Dimension Vista® System. In<br>individuals suspected of having<br>congestive heart failure (CHF),<br>measurements of NT-proBNP are<br>used as an aid in the diagnosis and<br>assessment of severity. The test is<br>further indicated for the risk<br>stratification of patients with acute | The PBNP method is an in vitro<br>diagnostic assay for the quantitative<br>measurement of N-terminal pro-brain<br>natriuretic peptide (NT-proBNP) in<br>human serum and plasma on the<br>Dimension Vista® System. In<br>individuals suspected of having<br>congestive heart failure (CHF),<br>measurements of NT-proBNP are used<br>as an aid in the diagnosis and<br>assessment of severity. The test is<br>further indicated for the risk<br>stratification of patients with acute |

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| | coronary syndrome and heart failure. | coronary syndrome and heart failure. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Technology<br>(detection) | Chemiluminescent | Chemiluminescent |
| Measuring<br>Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Monoclonal Sheep Antibody | Polyclonal Sheep Antibody |
| Cut-off | 125 pg/mL for patients less than 75<br>years old and 450 pg/mL for patients<br>75 years and older. | 125 pg/mL for patients less than 75<br>years old and 450 pg/mL for patients<br>75 years and older. |
| Analytical<br>Sensitivity | ≤ 5 pg/mL | ≤ 5 pg/mL |
| Functional<br>Sensitivity | ≤ 30 pg/mL | ≤ 30 pg/mL |
| Analytical<br>Specificity | Natrecor® shows no significant cross<br>reactivity, 0 or 125 pg/mL NT-PBNP;<br>sixteen other substances show no<br>significant cross reactivity. | Natrecor® shows no significant cross<br>reactivity, 0 or 125 pg/mL NT-PBNP;<br>sixteen other substances show no<br>significant cross reactivity. |
| Interferences | No significant interference from:<br>Bilirubin conjugated up to 60 mg/dL;<br>Bilirubin unconjugated up to 60 mg/dL;<br>Hemoglobin up to 1000 mg/dL;<br>Triglyceride up to 3000 mg/dL | No significant interference from:<br>Bilirubin conjugated up to 60 mg/dL;<br>Bilirubin unconjugated up to 60 mg/dL;<br>Hemoglobin up to 680 mg/dL;<br>Triglyceride up to 3000 mg/dL |
| Hook Effect | No effect up to 400,000 pg/mL | No effect up to 400,000 pg/mL |
| Calibration<br>Interval | 30 days, same reagent lot | 30 days, same reagent lot |
| Sample<br>Volume | 8 µL | 8 µL |

## Calibrator

| Feature | Dimension Vista® PBNP Flex®<br>Calibrator (KC676A) | Dimension Vista® PBNP Flex®<br>Calibrator (KC676) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | For the calibration of the N-Terminal<br>Pro-Brain Natriuretic Peptide (PBNP)<br>method for the Dimension Vista®<br>System. | For the calibration of the N-Terminal<br>Pro-Brain Natriuretic Peptide (PBNP)<br>method for the Dimension Vista®<br>System. |
| Analyte | Synthetic PBNP | Synthetic PBNP |
| Matrix | Bovine Albumin | Bovine Albumin |
| Form | Liquid, frozen | Liquid, frozen |
| Volume | Ten vials, two vials per level (A, B, C,<br>D, and E), 1.0 mL per vial. | Twelve vials, two vials per level (A, B,<br>C, D, E, and F), 1.0 mL per vial. |
| Levels | Five Levels, (0, 250, 1500, 12,000,<br>36.750 pg/mL) | Six levels, (0,125, 450, 1500, 12,000<br>and 36,750 pg/mL) |

# J. Conclusion:

The Dimension Vista® PBNP Flex® reagent cartridge (K6423A) and the Dimension Vista® PBNP Calibrator (KC676A) are substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423) and the Dimension Vista® PBNP Calibrator (KC676) both cleared under K061795. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread and head facing to the left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Mr. Victory M. Carrio RA/QS Compliance Manager P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101

MAY 1 6 2008

Re: k080578

Trade/Device Name: Dimension Vista® N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-Type Natriuretic Peptide Regulatory Class: Class II Product Code: NBC, JIT Dated: February 29, 2008 Received: March 03, 2008

Dear Mr. Carrio:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper. M.S., 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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## Indications For Use Statement

## 510(k) Number (if known):

KD80578

Device Name:

Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge (K6423A)

## Indications for 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.

Prescription Use X (Per 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 Benson

Sign-Off

ce of In Vitro Diagnostic Device Juation and Safety

Image /page/5/Picture/14 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'KQ80578'. The characters are written in a simple, slightly uneven style, suggesting they were written quickly or without strict adherence to a specific font. The overall impression is that of a handwritten code or identifier.

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## Indications For Use Statement

**510(k) Number (if known):** K

: K080578

### Device Name:

Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Calibrator (KC676A)

### Indications for Use:

The PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.

Prescription Use X (Per 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 Benam

... In Sign-Off

ിന്ce of In Vitro Diagnostic Device "ration and Safety

K080578

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