(74 days)
AxSYM ® BNP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
A device for the measurement of human B-Type Natriuretic Peptide (BNP) in EDTA plasma.
The Abbott AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) test was deemed substantially equivalent to the Biosite Triage BNP Test (K021317). The study conducted to demonstrate this equivalence compared the performance of the AxSYM BNP assay with the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation Coefficient (r) | 0.956 |
| Regression Slope (95% CI) | 1.12 (1.08 to 1.18) |
| Y-axis Intercept (95% CI) | -8 (-6 to -9) |
| Concordance at 100 pg/mL (95% CI) | 91.4% (87.7% to 94.2%) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: 313 specimens.
- Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the nature of the comparison study often implies prospectively collected samples for direct comparison.
3. Number and Qualifications of Experts for Ground Truth:
This study is a method comparison study comparing the performance of a new diagnostic device against a previously cleared predicate device, rather than assessing against a definitive clinical ground truth established by experts. Therefore, the concept of "experts used to establish ground truth" as it applies to subjective assessments (e.g., radiology interpretation) is not applicable here. The ground truth for the comparison was the result obtained from the predicate device (Biosite Triage BNP Test).
4. Adjudication Method:
Not applicable. As this was a method comparison study between two quantitative laboratory assays, there was no subjective interpretation or need for adjudication by experts in the test set. The comparison relied on direct numerical measurement concordance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This was not an MRMC study. It was a direct comparative effectiveness study between two diagnostic devices, not an assessment of human readers with or without AI assistance.
6. Standalone Performance:
Yes, in the context of a method comparison. The study evaluated the standalone performance of the AxSYM BNP assay by comparing its quantitative results against another standalone device (the Biosite Triage BNP Test). The results presented (correlation, slope, intercept, concordance) are measures of the AxSYM BNP assay's performance relative to the predicate, essentially demonstrating its "standalone" diagnostic output.
7. Type of Ground Truth Used:
The ground truth used was the results obtained from the predicate device, the Biosite Triage BNP Test (K021317). This is a form of device-to-device comparison where the previously cleared device serves as the reference standard.
8. Sample Size for the Training Set:
The document does not specify the sample size used for the training set. This information is typically proprietary to the manufacturer and not usually detailed in a 510(k) summary focused on substantial equivalence.
9. How the Ground Truth for the Training Set was Established:
The document does not provide details on how the ground truth for any training set might have been established. As a method comparison study proving substantial equivalence to a predicate, the focus is on the performance of the new device against the predicate, not on the internal development or training of the new device.
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Axis-Shield Diagnostics Ltd 28th Jan 2004
K033606 - AxSYM®BNP Page 1 of 2
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510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact
Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA Scotland, UK Tel : +44 1382 422000 Contact Person: Judith Finlayson Date Prepared : January 28, 2004
Device Name
| Proprietary Name: | Abbott AxSYM ® B-Type Natriuretic Peptide (BNP)Microparticle Enzyme Immunoassay (MEIA) test |
|---|---|
| Common name: | BNP test |
| Classification name: | Test, Natriuretic Peptide |
Device Description
A device for the measurement of human B-Type Natriuretic Peptide (BNP) in EDTA plasma.
Intended Use
The quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
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510(k) Summary
Substantial equivalence
The AxSYM BNP immunoassay is substantially equivalent to the Biosite Triage BNP Test cleared under K021317. Both products are intended for use in the quantitative determination of B-type natriuretic peptide.
Substantial equivalence - comparison
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The following information as presented in the Premarket Notification [510(k)] for AxSYM® BNP constitutes data supporting a substantially equivalent determination.
AxSYM BNP. is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of BNP in human EDTA plasma. AxSYM BNP is calibrated with AxSYM BNP Standard Calibrators. AxSYM BNP Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM system.
Substantial equivalence has been demonstrated between the AxSYM BNP assay and the Biosite Triage® BNP test device. The intended use of both BNP assays is for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. BNP values are used as an aid to the diagnosis assessment of severity of heart failure. Both assays are immunoassays that use antibodies specific for BNP. A Passing Bablok regression analysis between these two assays using 313 specimens with BNP values ranging from 0 to 3426 pg/mL, yielded a correlation coefficient of 0.956, a slope of 1.12 (95% Confidence Interval of 1.08 to 1.18) and a y-axis intercept of -8 (95% Confidence Interval of -6 to -9). Using a decision threshold of 100pg/mL for both tests, the concordance between the two assays was 91.4% (95% Confidence Interval of 87.7% to 94.2%).
In conclusion, these data demonstrate that the AxSYM BNP assay is as safe and effective as, and is substantially equivalent to the Biosite Triage BNP test device.
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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 and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 3 0 2004
Judith Finlayson, Ph.D. Regulatory Affairs Manager Axis-Shield Diagnostics The Technology Park Dundee DD2 1XA Scotland, UK
Re: K033606
Trade/Device Name: Abbott AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT; JJX Dated: November 13, 2003 Received: November 17, 2003
Dear Dr. Finlayson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease of the enactment date of the Medical Device Amendments, or to commerce prior to rial) 2011-11-17 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 r ou mays arovisions of the Act include requirements for annual registration, listing of general concern 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 If your device is elasoned (soo as or of ols. Existing major regulations affecting your device can may or subject to bank now in the may of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA be found in The Frid Level and our eming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Teass of actived that I Drivination that your device complies with other requirements of the Act that I DT has made a sond regulations administered by other Federal agencies. You must or any I oderal sthates and sequirements, including, but not limited to: registration and listing (21
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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,
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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INTENDED USE 4.
510 (k) number K03 360 مكاما3
Device Name
Abbott AxSYM ® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA)
Indications for Use
AxSYM ® BNP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
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Concurrence of XDRH, Office of Device Evaluation (ODF)
Carol C Benson for Jean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k03 3606
Prescription Use ................................... OR
Per 21 CFR 801.109
Over-the-Counter Use
Option format 1-2-96
§ 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.”