(74 days)
Not Found
No
The summary describes a standard immunoassay for measuring BNP levels and does not mention any AI or ML components. The performance study uses statistical methods (regression, concordance) common in analytical validation, not indicative of AI/ML.
No
The device is an in vitro diagnostic test used for aiding in the diagnosis and assessment of heart failure, not for treating it.
Yes
The "Intended Use / Indications for Use" states that "BNP values are used as an aid in the diagnosis and assessment of severity of heart failure." This explicitly indicates the device's diagnostic purpose.
No
The device description explicitly states it is a "Microparticle Enzyme Immunoassay (MEIA)" and is used "on the AxSYM System," indicating it is a laboratory assay kit and associated hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human B-type natriuretic peptide in human EDTA plasma". This involves testing a sample taken from the human body (plasma) in vitro (outside the body).
- Device Description: The description confirms it's a "device for the measurement of human B-Type Natriuretic Peptide (BNP) in EDTA plasma," reinforcing the in vitro nature of the test.
- Method: The method used is a "Microparticle Enzyme Immunoassay (MEIA)," which is a common technique used in in vitro diagnostic testing.
- Clinical Use: The BNP values are used as an "aid in the diagnosis and assessment of severity of heart failure," which is a clinical application of the test results.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBC; JIT; JJX
Device Description
A device for the measurement of human B-Type Natriuretic Peptide (BNP) in EDTA plasma.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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.
2
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