(112 days)
K021317, R021011, R031170
No
The summary describes a quantitative immunoassay for measuring BNP, a standard laboratory test, and does not mention any AI/ML components or capabilities.
No
The device is a diagnostic test intended to measure BNP levels to aid in the diagnosis and assessment of heart failure, not a device that provides therapy.
Yes
The "Intended Use / Indications for Use" section states: "The test is intended to be 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 and for the risk stratification of patients with heart failure." This clearly indicates its use in diagnostic processes.
No
The device is an in vitro diagnostic test kit that measures BNP in plasma specimens using immunoassay systems. It is a physical test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "In Vitro quantitative measurement" is explicitly stated in both the Intended Use and Device Description sections. This is a key characteristic of an IVD, meaning the test is performed outside of the living body.
- "in plasma specimens" indicates that the test is performed on a biological sample taken from the patient.
- "aid in the diagnosis and assessment of severity of congestive heart failure" and "risk stratification of patients" describe the clinical purpose of the test, which is to provide information for medical decision-making.
These elements clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.
Product codes (comma separated list FDA assigned to the subject device)
NBC
Device Description
The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant.
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)
Not Found
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.
K021317, R021011, R031170
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.”
0
510(k) Summary of Safety and Effectiveness II.
In accordance with the provisions of Section 4 of the Safe Medical Devices Act of 1990 and 21 CFR 807.92, the following summary is provided. Biosite requests that this document be maintained CONFIDENTIAL until such time that the product is cleared by the Food and Drug Administration via the 510(k) process and in accordance with the provisions of the Act.
A. Name and Address of Submitter
| Company Name:
Address: | Biosite Incorporated
9975 Summers Ridge Road
San Diego, CA 92121 |
|---------------------------|------------------------------------------------------------------------|
| Telephone: | (858) 805-2719 |
| Fax: | (858) 695-3823 |
| Contact Person: | Rachael S. Williamson, MS, RAC |
| Date Summary Prepared: | January 4, 2006 |
B. Product
Triage® BNP Test for the Beckman Coulter Immunoassay Systems
C. Predicate Devices
Biosite Triage BNP Test for the Beckman Coulter Immunoassay Systems (K033383) Biosite Triage BNP Test (K021317 and K051787)
Biosite Triage BNP Test (R021011 and R031170)
D. Device Description and Intended Use
The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.
1
E. Summary of Substantial Equivalence
Various peer-reviewed publications have described the utility of BNP measurements as an aid in the risk stratification of patients with heart failure. Higher BNP concentrations or the lack of a decrease in the BNP concentration from hospital admission to discharge indicate an increased risk of hospitalization or death in patients with heart failure.
The device and test method described in this Premarket Notification is identical in principle, reagents and procedure to its predecessor, the currently marketed Triage BNP Test for the Beckman Coulter Immunoassay (K033383).
Moreover, the Triage BNP Test (K051787) serves as the predicate method for the use of a circulating biomarker to provide prognostic information in patients with heart failure. The use of the Triage BNP Test for the Beckman Coulter Immunoassay Systems as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method.
F. Conclusion
In conclusion, the data presented in this Premarket Notification demonstrate the substantial equivalence of the Triage BNP Test for the Beckman Coulter Immunoassay Systems to currently marketed devices which have been reviewed and cleared through the 510(k) Premarket Notification process. Such data are a critical element in establishing the fundamental safety and effectiveness of the device and its appropriateness for commercial distribution.
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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 & Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three curved lines forming its wing or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 3 2006
Ms. Rachael Williamson Regulatory Affairs Specialist Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121
Re: K052789
Trade/Device Name: Triage 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 Dated: September 30, 2005 Received: October 31, 2005
Dear Ms. Williamson
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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Page 2 --
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052789
Device Name:
Triage BNP Test for the Beckman Coulter Immunoassay Systems
Indications For Use:
The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.
i Prescription Use AND/OR (Per 21 CFR 801.109)
Over-The-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ann Chappie
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k)