VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158

K060632 · Ortho-Clinical Diagnostics, Inc. · NBC · Jun 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060632
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: NBC · Clinical Chemistry
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

VITROS Immunodiagnostics NT-proBNP Reagent Pack: For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure. VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).

Device Story

The VITROS NT-proBNP assay is an automated in vitro diagnostic test performed on the VITROS Immunodiagnostic System. It utilizes human serum or plasma (EDTA or heparin) as input. The system employs a chemiluminescence immunoassay principle using coated microwells as the solid phase separation system. The device transforms the presence of NT-proBNP into a light signal, which is measured to provide a quantitative result. The system is operated by laboratory personnel in a clinical setting. The output is provided to healthcare providers to aid in the diagnosis of congestive heart failure, risk stratification for acute coronary syndrome, and assessment of heart failure severity and cardiovascular risk. This information assists clinicians in making diagnostic and management decisions, potentially improving patient outcomes through timely identification and monitoring of heart failure.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing comparing the VITROS NT-proBNP assay to the predicate device, including analytical sensitivity (<5.00 pg/mL), functional sensitivity (<10.0 pg/mL), measuring range (5.00-35,000 pg/mL), and hook effect evaluation.

Technological Characteristics

Immunometric assay; chemiluminescence detection. Reagents: streptavidin-coated wells, biotinylated sheep polyclonal anti-NT-proBNP, HRP-labeled sheep polyclonal anti-NT-proBNP. Energy source: VITROS Immunodiagnostic System. Reportable range: 5-35,000 pg/mL. No high-dose hook effect up to 500,000 pg/mL. Traceable to Roche Elecsys proBNP. Software: embedded in VITROS Immunodiagnostic System (k962919).

Indications for Use

Indicated for quantitative measurement of NT-proBNP in human serum/plasma to aid diagnosis of congestive heart failure (CHF), risk stratification of acute coronary syndrome and CHF, assessment of cardiovascular event/mortality risk in stable coronary artery disease patients, and assessment of heart failure severity in diagnosed CHF 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 Elecsys proBNP Immunoassay (K051382)
• VITROS Immunodiagnostic Products CEA Range Verifiers (K990984)

Submission Summary (Full Text)

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JUN -6 2006

Image /page/0/Picture/2 description: The image shows the logo for Ortho-Clinical Diagnostics, which is identified as a Johnson & Johnson company. Below the logo is the address "100 Indigo Creek Drive, Rochester, New York 14626-5101". The logo is in black and white.

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:

#### 1 Submitter Name, Address and Contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 [phone]

Contact Person: Leah Van De Water

#### 2 Preparation Date

Date 510(k) prepared: March 8, 2006

#### 3 Device Name

- VITROS Immunodiagnostic Products NT-proBNP Reagent Pack Common Name: NT-proBNP Reagent Pack Classification Name: B-Type natriuretic peptide test system (862.1117), Class II
- VITROS Immunodiagnostic Products NT-proBNP Calibrators Common Name: NT-proBNP Calibrators Classification Name: Calibrator (862.1150), Class II
- VITROS Immunodiagnostic Products NT-proBNP Range Verifiers Common Name: NT-proBNP Range Verifiers Classification: Quality control material (862.1660), Class I

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#### 4 Predicate Device

The VITROS Immunodiagnostic Products NT-proBNP Reagent Pack . VITROS Immunodiagnostic Product NT-proBNP Calibrators are substantially equivalent to the Roche Elecsys® proBNP Immunoassay K051382.

The VITROS Immunodiagnostic Products NT-proBNP Range Verifiers are substantially equivalent to the VITROS Immunodiagnostic Product CEA Range Verifiers previously cleared under K990984.

#### 5 Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of there main elements:

- . The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, the VITROS Immunodiagnostic Products NT-proBNP Calibrators, and the VITROS Immunodiagnostic Products NT-proBNP Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS NTproBNP assay) and VITROS Immunodiagnostic Products High Sample Diluent B.
- . The VITROS Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- . Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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# 4.0: 510(k) Summary

Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

#### б Device Intended Use

# VITROS Immunodiagnostics NT-proBNP Reagent Pack:

For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).

VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).

#### 7 Comparison to Predicate Device

The VITROS Immunodiagnostic Products NT-proBNP Reagent Pack and Calibrators is substantially equivalent to the Roche Elecsys proBNP Immunoassay K051382. The VITROS Immunodiagnostic Products NT-proBNP Range Verifiers are substantially equivalent to the VITROS Immunodiagnostic Products CEA Range Verifiers K990984.

Tables 1 through 3 compare the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, Calibrator and Range Verifier to the Roche Elecsys proBNP Immunoassay K051382 and VITROS Immunodiagnostic Products CEA Range Verifiers K990984.

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| Table 1 | Comparison of the VITROS Immunodiagnostic<br>Products NT-proBNP Reagent Pack to the Elecsys<br>proBNP Reagent Pack |
|---------|--------------------------------------------------------------------------------------------------------------------|
|---------|--------------------------------------------------------------------------------------------------------------------|

| Comparison<br>Device<br>Characteristic | VITROS<br>(new device) | Elecsys<br>(predicate device) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro<br>quantitative<br>measurement of N-<br>terminal pro Brain<br>Natriuretic Peptide<br>(NT-proBNP) in<br>human serum and<br>plasma (EDTA or<br>heparin) to aid in the<br>diagnosis of<br>congestive heart<br>failure and for the risk<br>stratification of acute<br>coronary syndrome<br>and congestive heart<br>failure. The test is<br>further indicated as an<br>aid in the assessment<br>of increased risk of<br>cardiovascular events<br>and mortality in<br>patients at risk for<br>heart failure who have<br>stable coronary artery<br>disease. The test can<br>also be used in the<br>assessment of heart<br>failure severity in<br>patients diagnosed<br>with congestive heart<br>failure. | For the in vitro quantitative<br>determination of N-terminal pro-<br>Brain natriuretic peptide in human<br>serum and plasma. The Elecsys<br>proBNP assay is used as an aid in<br>the diagnosis of individuals<br>suspected of have congestive heart<br>failure. The test is further<br>indicated for the risk stratifications<br>of patients with acute coronary<br>syndrome and congestive heart<br>failure. The test may also serve as<br>an aid in the assessment of<br>increased risk of cardiovascular<br>events and mortality in patients at<br>risk for heart failure who have<br>stable coronary artery disease. |
| Basic principle | Chemiluminescence<br>Immunoassay | Electrochemiluminescence<br>Immunoassay |
| Antibody | Biotinylated polyclonal<br>anti-NT-proBNP<br>(sheep) | Biotinylated polyclonal anti-NT-<br>proBNP (sheep) |
| Instrumentation | ECI/ECIQ<br>Immunodiagnostic<br>System: Automated<br>analyzer | Elecsys family of analyzers<br>(Elecsys 1010, Elecsys 2010 and<br>Elecsys Modular Analytics<br>Immunassay Analyzers |
| Sample type | Human serum and<br>plasma (EDTA and<br>heparin) | Human serum and plasma |
| Expected Values | Age and sex-related statistics Cut-offs of 125 pg/mL for patients<br>younger than 75 years and 450<br>pg/mL for patients<br>75 years and older | Age and sex-related statistics Cut-offs of 125 pg/ml for<br>patients younger than 75 years<br>and 450 pg/mL for patients 75<br>years and older |
| Measuring Range | 5.00-35,000 pg/mL | 5-35,000 pg/mL |
| Hook Effect | No high dose hook<br>effect up to 500,000<br>pg/mL | No high dose hook effect up to<br>300,000 pg/mL |
| Analytical Sensitivity | < 5.00 pg/mL | 5 pg/mL |
| Functional Sensitivity | < 10.0 pg/mL | < 50 pg/mL |

:

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# 4.0: 510(k) Summary

. . . . . .

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and the same of the same

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| Comparison | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | VITROS<br>(new device) | Elecsys<br>(predicate device) |
| Intended Use | For in vitro used in the<br>calibration of the VITROS<br>Immunodiagnostic System<br>for the quantitative<br>measurement of N-<br>terminal pro Brain<br>Natriuretic Peptide (NT-<br>proBNP) in human serum<br>and plasma (EDTA or<br>heparin). | Elecsys proBNP Calset is<br>used for calibrating the<br>quantitative proBNP assay<br>on the Elecsys 1010/2010<br>and MODULAR<br>ANALYTICS E170<br>immunoassay systems |
| Matrix | Liquid; NT-proBNP in<br>buffer with bovine serum<br>albumin and antimicrobial<br>agent | Lyophilized equine serum<br>matrix with added synthetic<br>NT-proBNP (1-76) |
| Levels | Cal 1 0 pg/mL<br>Cal 2 150 pg/mL<br>Cal 3 12,500 pg/mL | Cal 1 140 pg/mL<br>Cal 2 2700 pg/mL |

### Table 2 Comparison of the VITROS Immunodiagnostic Products NT-proBNP Calibrator to the Elecsys ® proBNP CalSet

:

Ortho-Clinical Diagnostics NT-proBNP 510(k)

.

:

ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ

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| Comparison | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | VITROS<br>(new device) | VITROS<br>(predicate device) |
| Intended Use | For in vitro use in<br>verifying the calibration<br>range of the VITROS<br>Immunodiagnostic System<br>when used for the<br>quantitative measurement<br>of N-terminal pro Brain<br>Natriuretic Peptide (NT-<br>proBNP) | For in vitro use in verifying<br>the calibration range of the<br>VITROS Immunodiagnostic<br>System when used for the<br>measurement of CEA. |
| Matrix | Liquid; Synthetic NT-<br>proBNP in buffer with<br>bovine serum albumin and<br>antimicrobial agent | Liquid; Human CEA in<br>buffer with bovine serum<br>albumin and antimicrobial<br>agent |
| Levels | Low and High | Low and High |

### Table 3 Comparison of the VITROS Immunodiagnostic Products NT-proBNP Range Verifiers to the VITROS Immunodiagnostic Products CEA Range Verifiers

#### 10 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS NT-proBNP Reagent Pack, VITROS NTproBNP Calibrator and VITROS NT-proBNP Range Verifiers are safe and effective for the stated intended uses and is substantially equivalent to the cleared predicate devices.

The VITROS Immunodiagnostic Products NT-proBNP Reagent Pack and the VITROS Immunodiagnostic Products NT-proBNP Calibrator were compared to the Elecsys proBNP Immunoassay (K051382). The VITROS Immunodiagnostic Products NT-proBNP Range Verifiers were compared to the VITROS Immunodiagnostic Products CEA Range Verifiers.

Ortho-Clinical Diagnostics NT-proBNP 510(k)

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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The background of the image is white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Leah Van De Water Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. Rochester, NY 14626-5101

JUN - 6 2006

k060632 Re:

> Trade/Device Name: VITROS Immunodiagnostic Products NT-proBNP Reagent Pack VITROS Immunodiagnostic Products NT-proBNP Calibrator VITROS Immunodiagnostic Products NT-proBNP Range Verifier Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC, JIT, JJX Dated: May 5, 2006 Received: May 8, 2006

Dear Ms. Water:

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 Garcia

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): ____________________________________________________________________________________________________________________________________________________

K060632

Device Name:

VITROS Immunodiagnostic Products NT-proBNP Reagent Pack VITROS Immunodiagnostic Products NT-proBNP Calibrator VITROS Immunodiagnostic Products NT-proBNP Range Verifier

Indications for Use:

VITROS Immunodiagnostics NT-proBNP Reagent Pack:

For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).

VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).

ﺮ ﺍ Prescription Use (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) | |
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| Office of In Vitro Diagnostic Device<br>Evaluation and Safety | |
| (510(k)) K060632 | |