MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

K032235 · Biosite Incorporated · NBC · Jan 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K032235
• Device Name: MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
• Applicant: Biosite Incorporated
• Product Code: NBC · Clinical Chemistry
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

The Triage® BNP test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test is also used for the risk stratification of patients with acute coronary syndromes.

Device Story

Triage® BNP test is a single-use fluorescence immunoassay; utilizes EDTA-anticoagulated capillary whole blood, venous whole blood, or plasma. Device contains stabilizers, murine BNP monoclonal antibodies, and fluorescently labeled BNP polyclonal antibodies. User adds 250 μL specimen to test device port; inserts into Triage® Meter. Meter automatically performs analysis; detects fluorescence intensity in measurement zone; correlates fluorescence to BNP concentration. Used in clinical settings by professionals. Output provides quantitative BNP concentration; aids diagnosis/severity assessment of congestive heart failure and risk stratification for acute coronary syndromes. Benefits include rapid, point-of-care diagnostic information for heart failure management.

Clinical Evidence

Bench testing only. Precision evaluated via ANOVA model over 12 days; whole blood precision compared to plasma. Linearity confirmed via gravimetric dilution (recovery 92.3-105.8%). Analytical sensitivity <5 pg/mL. Specificity tested against common drugs, proteins, and peptides with no significant interference. Matrix comparison (n=67) between capillary and venous whole blood showed no significant differences.

Technological Characteristics

In vitro diagnostic immunoassay; quantitative measurement of BNP; utilizes Triage Meter for signal detection; compatible with capillary whole blood, venous whole blood, and EDTA-anticoagulated plasma.

Indications for Use

Indicated for patients requiring assessment of congestive heart failure (CHF) severity or risk stratification for acute coronary syndromes. Applicable to adults; no specific age or gender contraindications noted.

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® B-Type Natriuretic Peptide (BNP) test (K021317)

Submission Summary (Full Text)

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K632235

JAN 2 8 2004

## Biosite Incorporated Triage® B-Type Natriuretic Peptide (BNP) Test

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | January 13, 2003 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Biosite Incorporated |
| Address: | 11030 Roselle Street<br>San Diego, CA 92121<br>Phone [phone]<br>Fax [phone] |
| Contact: | Jeffrey R. Dahlen, Ph.D.<br>Clinical & Regulatory Affairs<br>Principal Scientist |
| Device: | Trade/Proprietary Name:<br>Triage® B-Type Natriuretic Peptide (BNP) Test |
| | Common/Usual Name:<br>BNP Test |
| Classification: | Office of In Vitro Diagnostic Device Evaluation and<br>Safety (OIVD)<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code - NBC |
| Predicate Devices: | Triage® B-Type Natriuretic Peptide (BNP) Test |
| Device Description and Intended Use: | |

The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is 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.

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Assessment of Performance:

A comparison between Triage® BNP Test results obtained from capillary whole blood specimens and venous whole blood specimens from the same individual was performed. A total of 67 paired samples were evaluated. All results were blinded.

43.3% of the capillary blood samples were obtained using a single finger stick, 35.8% of the samples were obtained using two finger sticks, and 20.9% of the samples were obtained using three or more finger sticks. Data were analyzed by linear regression and potential differences in the data sets were evaluated using the Wilcoxon Signed Ranks test, with p < 0.05 indicating a significant difference in the data sets. Analyses were performed based on the number of fingersticks required to obtain enough sample, and the entire data set was analyzed. The results of the analyses indicate that capillary whole blood is a suitable sample for use with the Triage® BNP Test and is equivalent to results obtained from venous whole blood. Results obtained from capillary whole blood were not significantly different from results obtained using venous whole blood. The correlation was not influenced by the number of fingersticks needed to collect enough sample to run the test.

Imprecision studies using whole blood samples spiked with purified BNP indicated that the test imprecision using whole blood is comparable to the imprecision using EDTA-anticoagulated plasma

The results of the study indicate that capillary whole blood is a suitable Conclusion: sample for use with the Triage® BNP Test and is equivalent to results obtained from venous whole blood.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 2004

Jeffrev R. Dahlen, Ph.D. Clinical & Regulatory Affairs Principal Scientist Biosite Incorporated 11030 Roselle Street San Diego, CA 92121

Re: k032235

Trade/Device Name: Triage® B-Type Natriuretic Peptide (BNP) Test Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: November 25, 2003 Received: November 26, 2003

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, 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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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/dsma/dsmamain.html.

Sincerely yours.

Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, 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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510(k) Number (if known): K03 2235

Device Name:

Triage® B-Type Natriuretic Peptide (BNP) Test

Indications for Use:

The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of scverity 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k032235

Prescription Use (Per 21CFR 801.109) OR

Over-The-Counter Use