(61 days)
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.
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.
This document describes a 510(k) summary for the Triage B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems, submitted by Biosite Incorporated. The submission aims to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through its substantial equivalence to a previously cleared predicate device, the Biosite Triage BNP test. The key performance metric provided is the correlation with the predicate method.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Performance | Method comparison with predicate showing strong correlation. | Passing-Bablok regression: slope of 1.00, intercept of -0.15, correlation coefficient of 0.95. |
| High agreement at a clinical cutoff (100 pg/mL). | At 100 pg/mL cutoff, 96.1% agreement with predicate. | |
| Equivalence to Predicate | Analytical performance characteristics equivalent to predicate. | "The analytical performance characteristics are equivalent to the predicate method..." |
| Interchangeability of results with predicate. | "...Triage BNP results can be used interchangeably." |
No specific numerical acceptance criteria (e.g., minimum correlation coefficient, minimum agreement) are explicitly stated in the provided text for the new device, beyond the demonstrated strong correlation and agreement with the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 412 EDTA plasma samples.
- Data Provenance: Not specified in the provided text. It is not mentioned if the data is from a specific country or if it is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for this submission. The "ground truth" in this context is established by the measurements obtained from the predicate device, not through expert consensus or interpretation of images/clinical cases. The study involves comparing the analytical measurements of two different immunoassay systems.
4. Adjudication Method for the Test Set
This information is not applicable for this type of analytical validation study. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts independently review and judge ambiguous cases, often in radiology or pathology. Here, the "truth" for comparison is the measurement from a reference (predicate) method.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test for quantitative measurement of a biomarker, not an AI-powered diagnostic imaging or clinical decision support tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of an IVD immunoassay. The device itself is a "standalone" system in the sense that it performs the measurement. Its performance is evaluated analytically, not as an algorithm's interpretation that might require human oversight or input. The study compared the device (performing its measurement) to a predicate device (performing its measurement).
7. The Type of Ground Truth Used
The "ground truth" for this study was the measurements provided by the predicate device, the Biosite Triage BNP test. The study aimed to demonstrate that the new device's measurements correlated strongly and agreed with those of the already-cleared predicate device.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the conventional sense for this type of device. Immunoassays are typically developed and validated through a series of analytical studies (e.g., linearity, precision, interference, method comparison) rather than "training" using large datasets like machine learning models. The development likely involved internal studies to optimize reagents and assay parameters, but these are not referred to as a "training set" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and "ground truth" establishment for it is not directly applicable here in the same way it would be for AI/ML models. The "ground truth" for developing and validating the assay (if conceptually mapped) would have been established through a combination of:
- Reference materials.
- Analytically defined samples (e.g., spiked samples, dilutions to establish linearity).
- Correlation with established laboratory methods and clinical samples during the development phase of the original Triage BNP test (the predicate), and then ensuring the new system maintains that performance.
The provided document specifically states: "The test uses the same antibodies and calibrators traceable to the same BNP gold standard as the previously cleared Biosite Triage BNP Test." This implies that the 'ground truth' or reference for the new device is ultimately the same 'gold standard' used for the predicate, ensuring consistency between the two.
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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 StreetSan 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
-
- Trade Name
Triage B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems
- Trade Name
-
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
§ 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.”