(83 days)
Not Found
No
The summary describes a fluorescence immunoassay and mentions no AI/ML terms or concepts.
No
The device is used for diagnostic purposes (aid in the diagnosis and assessment of heart failure, and risk stratification), not for treating a disease or condition.
Yes
The device is described as an "aid in the diagnosis of heart failure," which directly indicates a diagnostic purpose.
No
The device description explicitly states it is a "fluorescence immunoassay" and is used with "Triage Meter or Triage MeterPlus," indicating it is a hardware-based test and meter system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the test is for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in biological specimens (whole blood or plasma). This measurement is used as an aid in the diagnosis, assessment, and risk stratification of heart conditions. This aligns directly with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's a fluorescence immunoassay used with a meter to measure a substance in biological specimens. This further supports its classification as an IVD.
- Specimen Type: The test uses EDTA anticoagulated whole blood or plasma specimens, which are biological samples taken from the human body.
The information provided strongly indicates that the Triage® BNP Test is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Triage® BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative Natriuretic Peptide measurement of B-Type (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the:
- Diagnosis of heart failure .
- Assessment of heart failure severity of .
- Risk stratification of patients with acute coronary syndromes .
- 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 a rapid, point of care fluorescence immunoassay to be used with the Triage Meters for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. 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.
Mentions image processing
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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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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: | Biosite Incorporated |
|---|---|
| Address: | 9975 Summers Ridge Road |
| San Diego, CA 92121 | |
| Telephone: | (858) 805-2822 |
| Fax: | (858) 695-3823 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | September 17, 2005 |
B. Product
Triage® BNP Test
C. Predicate Devices
Biosite Triage BNP Test (K021317) Roche Elecsys ProBNP Immunoassay (K032646)
D. Device Description and Intended Use
The Triage BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meters for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. 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.
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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 the currently marketed Triage BNP Test (K021317).
The Elecsvs ProBNP Immunoassav (K032646) is used as a predicate method for the use of a circulating biomarker to provide prognostic information in patients with heart failure. Although the test measures a different analyte, i.e. NT-proBNP, the use of the Triage BNP Test 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 to predicate methods.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
SEP 2 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jeffrey Dahlen, Ph.D. Director, Clinical & Regulatory Affairs Biosite Incorporated 11030 Roselle Street San Diego, CA 92121
Re: K051787
Trade/Device Name: Triage BNP Test Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: June 30, 2005 Received: July 1, 2005
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. Iisting 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).
ﺮ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
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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 (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,
Carol C. Benem
Carol C. Benson, M.A. Acting 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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Indications for Use
510(k) Number (if known):
KOSI187
Device Name:
Triage BNP Test
Indications For Use:
The Triage® BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative Natriuretic Peptide measurement of B-Type (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the:
- Diagnosis of heart failure .
- Assessment of heart failure severity of .
- Risk stratification of patients with acute coronary syndromes .
- Risk stratification of patients with heart failure .
Prescription Use AND/OR X (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)
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) kos1787
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Division Sign-Off
e of In/Vitro Diagnostic Device aluation and Saf
5100k05/717