TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

K033383 · Biosite Incorporated · NBC · Dec 23, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033383
• Device Name: TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
• Applicant: Biosite Incorporated
• Product Code: NBC · Clinical Chemistry
• Decision Date: Dec 23, 2003
• 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 Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in 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. The test also is used for the risk stratification of patients with acute coronary syndromes.

Device Story

The Triage BNP test is an in vitro diagnostic assay for quantitative measurement of B-type natriuretic peptide (BNP) in EDTA plasma. The device utilizes a two-site immunoenzymatic 'sandwich' assay principle; patient plasma is incubated with paramagnetic particles coated with mouse omniclonal anti-human BNP antibody and a mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate. After magnetic separation and washing, a chemiluminescent substrate (Lumi-Phos 530) is added; light emission, measured by a luminometer, is directly proportional to BNP concentration. The assay is performed on Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725, UniCel DxI 800) in clinical laboratory settings. Results are determined via a stored multi-point calibration curve. Clinicians use the output (BNP concentration) to aid in diagnosing congestive heart failure, assessing disease severity, and risk-stratifying patients with acute coronary syndromes. The test provides objective biochemical data to support clinical decision-making regarding heart failure management.

Clinical Evidence

Method comparison study performed using 412 EDTA plasma samples across the measurable range. Comparison against predicate Biosite Triage BNP test showed a correlation of 0.95, slope of 1.00, and intercept of -0.15 (Passing-Bablok regression). Applying a 100 pg/mL cutoff yielded 96.1% agreement between methods.

Technological Characteristics

Two-site immunoenzymatic 'sandwich' assay. Reagents: paramagnetic particles coated with mouse omniclonal anti-human BNP antibody, mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate. Chemiluminescent detection (Lumi-Phos 530). Standardized via prEN ISO 17511. Analyzers: Beckman-Coulter Access/Access 2/Synchron LXi 725/UniCel DxI 800. Quantitative measurement.

Indications for Use

Indicated for patients requiring diagnosis or severity assessment of congestive heart failure and risk stratification for acute coronary syndromes. Uses EDTA plasma specimens.

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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# DEC 2 3 2003

### 510(k) Summary

## Triage® B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### 510(k) Number: K033383

#### Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|---------------------------------------------|
| Address: | 11030 Roselle Street<br>San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 12/19/03 |

#### Device Names

- 1. Trade Name
Triage B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems

- Common / Usual Name 2.
#### BNP Test

- ന് Classification Name
B-Type Natriuretic Peptide Test System

#### Device Description and Intended Use

The Triage BNP test for the Beckman Coulter Immunoassay Systems reagents consist of reagent packs, calibrators, QC, substrate and wash buffer. The test uses the same antibodies and calibrators traceable to the same BNP gold standard as the previously cleared Biosite Triage BNP Test.

The Triage BNP test is intended for use with the Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the

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diagnosis and assessment of severity of congestive heart failure (also referred to diagnosis and assocssmont of occused for the risk stratification of patients with acute coronary syndromes.

### Comparison to Predicate Method

A method comparison was performed using 412 EDTA plasma samples with A method ournpanes throughout the measurable range of the test. A Passing-DNF oonloontrations that sis of the Triage BNP test for the Beckman Coulter Dablook regression analytis us the predicate Biosite Triage BNP test described a immunodody Cycloth a slope of 1.00, intercept of -0.15 and a correlation imour relations of 0.95. Furthermore, applying a cutoff of 100 pg/mL yielded 96.1% oochronit of 0.001 1 atwo methods. The analytical performance characteristics are equivalent to the predicate method, as well as other Beckman Coulter Immunoassay System tests. Conclusion

The Triage BNP test for the Beckman Coulter Immunoassay Systems is The Thage ENF to the predicate method. The results from comparison studies, coupled with the fact that the test uses the same antibodies as the stadies, obaptou with that Triage BNP results can be used interchangeably.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 2003

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

k033383 Re:

> Trade/Device Name: Triage® B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems Regulation Number: 21 CFR 862.1117 Regulation Name: B-Type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT; JJX Dated: October 22, 2003 Received: October 24, 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): KO33383
510(k) Number (if known): KO33383

510(k) Number (if known):

Device Name: Triage® B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems

Indications For Use:

The Triage® BNP test is intended for use with the Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725, and UniCel Dxl Innianododay of closed of exemplement of B-Type Natriuretic Peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is used (GNP) in plainta eposis and assessment of severity of congestive 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
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

Over-The Counter Use

Prescription Use
(Per 21 CFR 801.109) OR

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