(61 days)
Biosite Triage BNP Test
Biosite Triage BNP Test
No
The summary describes a standard immunoassay test and does not mention any AI or ML components.
No
The device is an in vitro diagnostic test used to measure B-Type Natriuretic Peptide (BNP) in plasma specimens for the assessment of severity of congestive heart failure and risk stratification of patients with acute coronary syndromes. It is a diagnostic tool, not a therapeutic device.
Yes
The device is intended for the quantitative determination of B-Type Natriuretic Peptide (BNP) in plasma specimens, and the test is used as an aid in the diagnosis and assessment of severity of congestive heart failure, and for risk stratification of patients with acute coronary syndromes. These uses directly aid in diagnosing and assessing medical conditions.
No
The device description explicitly states that the device consists of "reagent packs, calibrators, QC, substrate and wash buffer," which are all physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test is for the "quantitative determination of B-Type Natriuretic Peptide (BNP) in plasma specimens using EDTA as the anticoagulant." This involves analyzing a biological sample (plasma) outside of the body to provide information about a patient's health status (assessment of severity of congestive heart failure and risk stratification for acute coronary syndromes). This is a core characteristic of an IVD.
- Device Description: The description mentions "reagents consist of reagent packs, calibrators, QC, substrate and wash buffer." These are all components typically used in laboratory-based diagnostic tests performed on biological samples.
- Performance Studies: The description of the performance study involves analyzing "EDTA plasma samples" and comparing the results to a "predicate Biosite Triage BNP test." This further confirms that the device is used to test biological samples.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body, to detect diseases, conditions, or infections. This description perfectly aligns with the information provided for the Triage BNP test.
N/A
Intended Use / 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 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.
Product codes
NBC, JIT, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A method comparison was performed using 412 EDTA plasma samples with BNP concentrations that span throughout the measurable range of the test. A Passing-Bablok regression analysis of the Triage BNP test for the Beckman Coulter Immunoassay Systems versus the predicate Biosite Triage BNP test described a slope of 1.00, intercept of -0.15 and a correlation coefficient of 0.95. Furthermore, applying a cutoff of 100 pg/mL yielded 96.1% overall agreement between the two methods. The analytical performance characteristics are equivalent to the predicate method, as well as other Beckman Coulter Immunoassay System tests.
Key Metrics
Not Found
Predicate Device(s)
Biosite Triage BNP Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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 |
| San Diego, CA 92121 | |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 12/19/03 |
Device Names
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- Trade Name
Triage B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems
- Trade Name
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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 (301) 594-3084. 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/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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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