TRIAGE BNP TEST, MODEL 98000XR

K051787 · Biosite Incorporated · NBC · Sep 22, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051787
• Device Name: TRIAGE BNP TEST, MODEL 98000XR
• Applicant: Biosite Incorporated
• Product Code: NBC · Clinical Chemistry
• Decision Date: Sep 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

The Triage® BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative Natriuretic Peptide measurement of B-Type (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the: - Diagnosis of heart failure . - Assessment of heart failure severity of . - Risk stratification of patients with acute coronary syndromes . - Risk stratification of patients with heart failure .

Device Story

Triage BNP Test is a single-use, point-of-care fluorescence immunoassay for quantitative measurement of BNP in EDTA whole blood or plasma. Device contains anti-BNP monoclonal and polyclonal antibodies labeled with fluorescent dye. User adds specimen to test device via transfer pipette; device inserted into Triage Meter or Triage MeterPlus. Meter automatically performs analysis; detects fluorescence in measurement zone proportional to BNP concentration. Results aid clinicians in diagnosing heart failure, assessing severity, and risk stratifying patients with heart failure or acute coronary syndromes.

Clinical Evidence

No new clinical bench or prospective trials performed. Evidence for expanded indication consists of five peer-reviewed scientific articles and a systematic review (Doust et al., BMJ 2005) evaluating BNP as a prognostic indicator in heart failure patients. All cited studies utilized the Biosite Triage BNP device.

Technological Characteristics

Quantitative fluorescent immunoassay; single-use device; contains anti-BNP monoclonal/polyclonal antibodies; fluorescent dye label; solid phase immobilization. Requires Triage Meter or Triage MeterPlus for analysis. Analyzes EDTA anti-coagulated whole blood or plasma.

Indications for Use

Indicated for patients requiring quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anti-coagulated whole blood or plasma to aid in diagnosis of heart failure, assessment of heart failure severity, and risk stratification for patients with acute coronary syndromes or 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

• Triage BNP Test (k003475)
• Triage BNP Test (k021317)
• Triage BNP Test (k032235)

Submission Summary (Full Text)

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K051787

#### 510(k) Summary of Safety and Effectiveness II.

In accordance with the provisions of Section 4 of the Safe Medical Devices Act of 1990 and 21 CFR 807.92, the following summary is provided. Biosite requests that this document be maintained CONFIDENTIAL until such time that the product is cleared by the Food and Drug Administration via the 510(k) process and in accordance with the provisions of the Act.

### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|--------------------------|
| Address: | 9975 Summers Ridge Road |
| | San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | September 17, 2005 |

# B. Product

Triage® BNP Test

### C. Predicate Devices

Biosite Triage BNP Test (K021317) Roche Elecsys ProBNP Immunoassay (K032646)

# D. Device Description and Intended Use

The Triage BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meters for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.

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# E. Summary of Substantial Equivalence

Various peer-reviewed publications have described the utility of BNP measurements as an aid in the risk stratification of patients with heart failure. Higher BNP concentrations or the lack of a decrease in the BNP concentration from hospital admission to discharge indicate an increased risk of hospitalization or death in patients with heart failure.

The device and test method described in this premarket notification is identical in principle, reagents and procedure to the currently marketed Triage BNP Test (K021317).

The Elecsvs ProBNP Immunoassav (K032646) is used as a predicate method for the use of a circulating biomarker to provide prognostic information in patients with heart failure. Although the test measures a different analyte, i.e. NT-proBNP, the use of the Triage BNP Test as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method.

# F. Conclusion

In conclusion, the data presented in this Premarket Notification demonstrate the substantial equivalence of the Triage BNP Test to predicate methods.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

SEP 2 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jeffrey Dahlen, Ph.D. Director, Clinical & Regulatory Affairs Biosite Incorporated 11030 Roselle Street San Diego, CA 92121

Re: k051787

Trade/Device Name: Triage BNP Test Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: June 30, 2005 Received: July 1, 2005

Dear Dr. Dahlen:

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. Iisting 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).

ﺮ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

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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,

Carol C. Benem

Carol C. Benson, M.A. Acting 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):

KOSI187

Device Name:

Triage BNP Test

Indications For Use:

The Triage® BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative Natriuretic Peptide measurement of B-Type (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the:

- Diagnosis of heart failure .
- Assessment of heart failure severity of .
- Risk stratification of patients with acute coronary syndromes .
- Risk stratification of patients with heart failure .

Prescription Use AND/OR X (Per 21 CFR 801.109)

Over-The-Counter Use (Per 21 CFR 807 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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