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 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.

Device Description

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 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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Dimension Vista™ PBNP reagent cartridge and calibrator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with explicit statistical results.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not present in this type of summary document, as the focus is on comparative performance against an already approved device rather than establishing de novo performance against a predefined independent standard.

However, based on the information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "substantial equivalence" to the predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516). The "reported device performance" are the features and characteristics of the new device that are compared to the predicate.

Feature	Implicit Acceptance Criteria (similar to predicate)	Dimension Vista® PBNP (Reported Performance)	Roche Elecsys® proBNP (Predicate Performance for comparison)
Intended Use	Quantitative NT-proBNP measurement in human serum/plasma; aid in diagnosis/assessment of CHF severity; risk stratification for ACS/HF.	Quantitative NT-proBNP measurement in human serum/plasma; aid in diagnosis/assessment of CHF severity; risk stratification for ACS/HF.	Quantitative NT-proBNP measurement in human serum/plasma; aid in diagnosis of CHF; risk stratification for ACS/CHF.
Assay Type	Immunoassay	Immunoassay (chemiluminescent)	Immunoassay (electrochemiluminescent)
Reportable Range	5 - 35,000 pg/mL	5 - 35,000 pg/mL	5 - 35,000 pg/mL
Antibody	Polyclonal (sheep) antibody	Roche Diagnostics' polyclonal (sheep) antibody	Polyclonal (sheep) antibody
Cut-off	125 pg/mL (<75 years), 450 pg/mL (≥75 years)	125 pg/mL (<75 years), 450 pg/mL (≥75 years)	125 pg/mL (<75 years), 450 pg/mL (≥75 years)
Analytical Sensitivity	≤ 5 pg/mL	≤ 5 pg/mL	5 pg/mL
Functional Sensitivity	Similar to predicate (< 50 pg/mL)	≤ 30 pg/mL	< 50 pg/mL
Analytical Specificity	No significant cross-reactivity with Natercor® and other substances.	Natercor®: no significant cross-reactivity (0 or 125 pg/mL NT-proBNP); 16 other substances: no significant cross-reactivity.	Natercor®: no significant cross-reactivity (300 or 3000 pg/mL NT-proBNP); 16 other substances: no significant cross-reactivity.
Interferences (Bilirubin)	No significant interference up to 35 mg/dL	No significant interference up to 60 mg/dL	No significant interference up to 35 mg/dL
Interferences (Hemoglobin)	No significant interference up to 1.4 g/dL	No significant interference up to 680 mg/dL	No significant interference up to 1.4 g/dL
Interferences (Triglycerides)	No significant interference up to 4000 mg/dL	No significant interference up to 3000 mg/dL	No significant interference up to 4000 mg/dL
Interferences (Rheumatoid Factors)	No significant interference up to 1500 IU/mL	No significant interference up to 500 IU/mL	No significant interference up to 1500 IU/mL
Reference	Roche NT-proBNP antibody (1-76)	Roche NT-proBNP antibody (1-76)	Roche NT-proBNP antibody (1-76)
Hook Effect	No effect up to 300,000 pg/mL	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	30 days - same reagent lot
Sample Volume	(Not an equivalence criteria, but a feature)	8 uL	20 uL

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Comparative data for human secure and plasma samples demonstrate good analytical and clinical agreement between the r nethods." However, specific sample sizes for the test set and data provenance (e.g., country of origin, retrospective/prospective) are not provided in this summary. This information would typically be in a more detailed study report.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as this is an in vitro diagnostic device for quantitative measurement, and the "ground truth" for its performance is typically established through analytical studies (e.g., linearity, precision, interference) rather than expert interpretation of images or clinical cases in the same way a diagnostic imaging AI might require. The "ground truth" for NT-proBNP levels would be the actual concentration of the analyte, typically determined by reference methods or gravimetric preparation for spiked samples.

4. Adjudication Method for the Test Set

This is not applicable/not provided given the nature of the device as an in vitro diagnostic assay directly measuring an analyte. Adjudication methods are typically used in studies involving human interpretation or clinical endpoint assessments, not for analytical performance of a biochemical assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is an in vitro diagnostic assay, not an AI system designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is implicitly the primary performance claim. The device (Dimension Vista™ PBNP method) is a standalone in vitro diagnostic assay. Its performance is measured directly by its analytical characteristics (sensitivity, specificity, linearity, precision, interference, etc.) in quantifying NT-proBNP. The entire submission focuses on the standalone performance of this assay in comparison to the predicate.

7. The Type of Ground Truth Used

For analytical performance (e.g., precision, linearity, interference), the ground truth is established by:

Known concentrations of NT-proBNP in prepared samples (e.g., spiked samples, calibrator materials).
Reference methods or comparison to established, legally marketed devices (the predicate in this case) for patient samples.
Clinical outcomes for the intended use in diagnosis and risk stratification (though the summary states "good analytical and clinical agreement," specific clinical outcome data or its use as ground truth is not detailed here for the studies presented).

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. For biochemical assays, a "training set" might refer to samples used during assay development and optimization, but specific sizes are not typically reported in this type of regulatory document unless it's a machine learning algorithm. The closest equivalent might be the samples used to establish analytical performance characteristics.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As above, for biochemical assays, "ground truth" during development would be based on known concentrations of the analyte or reliable reference methods.

Summary

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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.P.O. Box 6101Newark, DE 19714
Contact Information:	Dade Behring Inc.P.O. Box 6101Newark, DE 19714Attn: Pamela A. JurgaTel: 302-631-8891
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

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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

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(K032646/K022516)
Intended Use	For the in vitro quantitativemeasurement of N-terminal pro-brain natriuretic peptide in humanserum and plasma. In individualssuspected of having congested heartfailure (CHF) measurements of NT-proBNP are used as an aid in thediagnosis and assessment ofseverity. The test is furtherindicated for the risk stratificationof patients with acute coronarysyndrome and heart failure.	For the in vitro quantitativedetermination of N-terminal pro-brainnatriuretic peptide in human serumand plasma. The Elecsys proBNPassay is used as an aid in thediagnosis of individuals suspected ofhaving congestive heart failure.The test is further indicated for therisk stratification of patients withacute coronary syndrome andcongestive heart failure.
Assay Type(detection)	immunoassay(chemiluminescent)	immunoassay(electrochemiluminescent)
Reportable Range	5 - 35,000 pg/mL	5 - 35,000 pg/mL
Antibody	Roche Diagnostics'polyclonal (sheep) antibody	polyclonal (sheep) antibody
Cut-off	125 pg/mL for patients less than 75years and 450 pg/mL for patients 75years and older	125 pg/mL for patients less than 75years and 450 pg/mL for patients 75years and older
AnalyticalSensitivity	≤ 5 pg/mL	5 pg/mL
FunctionalSensitivity	≤ 30 pg/mL	< 50 pg/mL
AnalyticalSpecificity	Natercor® shows no significantcross reactivity, 0 or 125 pg/mLNT-proBNP; sixteen othersubstances show no significantcross reactivity	Natercor® shows no significant crossreactivity, 300 pg/mL or 3000 pg/mLNT-proBNP; sixteen other substancesshow no significant cross reactivity
Interferences	No significant interference from:bilirubin ,conj. up to 60 mg/dL	No significant interference from:bilirubin up to 35 mg/dLhemoglobin up to 1.4 g/dL
	hemoglobin up to 680 mg/dLtriglycerides up to 3000 mg/dLrheumatoid factors up to 500 IU/mL	triglycerides up to 4000 mg/dLrheumatoid 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(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 pervial for level A, C and D, 1.5 mLper vial for level B	1 mL for each level
Levels	4 levels (0, 125, 1500, and 36750pg/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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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

Calibrator

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

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

Page 1 of 1

(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

Regulation Number and Section

§ 862.1117 B-type natriuretic peptide test system.

(a)
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.(b)
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.”