(67 days)
Not Found
Dade Stratus Cardiac Troponin-I, Dade Dimension RxL Cardiac Troponin-I
No
The summary describes an in vitro diagnostic test that measures a specific biomarker (BNP) using a meter. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance study focuses on the correlation between BNP levels and clinical outcomes, not on an AI/ML algorithm's performance.
No
The device is an in vitro diagnostic test used to measure biomarkers and aid in diagnosis and risk stratification, not to provide direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure."
No
The device description explicitly states it is an "in vitro quantitative measurement" using a "Triage® Meter," indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is for "rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens". The term "in vitro" is the key indicator of an IVD.
- Device Description: The "Device Description" section reiterates the same intended use, again using the term "in vitro".
- Input Imaging Modality and Anatomical Site: The fact that these are listed as "Not Applicable (In vitro diagnostic test)" further confirms that it is an IVD and not an imaging device used on a patient's body.
- Sample Type: The test uses "human whole blood or plasma specimens", which are biological samples tested outside of the body, characteristic of an IVD.
Therefore, based on the provided information, the Triage® BNP Test is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is 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.
Product codes (comma separated list FDA assigned to the subject device)
NBC
Device Description
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is 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.
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)
BNP concentrations measured in patients with acute coronary syndromes (ACS) or cardiovascular disease provide prognostic information about the patient's risk for death and the development of CHF. Statistically significant increases in death, future myocardial infarction, and CHF have been associated with higher BNP concentrations measured within the first 72 hours after the onset of ACS symptoms. In a recent clinical study, BNP concentrations were evaluated in an observational, retrospective manner in patients with ACS (consisting of unstable angina, myocardial infarction with ST-segment elevation, or myocardial infarction without ST-segment elevation). BNP measurements were performed on specimens obtained within 72 hours after the onset of ischemic discomfort from a population of 2525 high-risk ACS patients that met standard diagnostic criteria for ACS. Patients whose BNP concentration was at least 80 pg/mL had higher rates of death, myocardial infarction, and CHF both at 30 days and at 10 months after presentation than patients whose BNP concentration was below 80 pg/mL. In this population of patients with ACS. BNP measurements within the first 72 hours after the onset of symptoms provide useful predictive information to aid in the risk stratification of patients with ACS.
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.
Triage® BNP Test
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.
Dade Stratus Cardiac Troponin-I, Dade Dimension RxL Cardiac Troponin-I
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
Triage® B-Type Natriuretic Peptide (BNP) Test
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K021317
Name and Address of Submitter
| Company Name: | Biosite Diagnostics, Incorporated |
|---|---|
| Address: | 11030 Roselle Street |
| San Diego, CA 92121 | |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 6/28/02 |
Device Names
-
- Trade Name
Triage® B-Type Natriuretic Peptide (BNP) Test
- Trade Name
-
- Common / Usual Name
BNP Test
-
- Classification Name
B-Type Natriuretic Peptide Test System
- Classification Name
Device Description and Intended Use
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is 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.
1
Summary of Clinical Data
BNP concentrations measured in patients with acute coronary syndromes (ACS) or cardiovascular disease provide prognostic information about the patient's risk for death and the development of CHF. Statistically significant increases in death, future myocardial infarction, and CHF have been associated with higher BNP concentrations measured within the first 72 hours after the onset of ACS symptoms. In a recent clinical study, BNP concentrations were evaluated in an observational, retrospective manner in patients with ACS (consisting of unstable angina, myocardial infarction with ST-segment elevation, or myocardial infarction without ST-segment elevation). BNP measurements were performed on specimens obtained within 72 hours after the onset of ischemic discomfort from a population of 2525 high-risk ACS patients that met standard diagnostic criteria for ACS. Patients whose BNP concentration was at least 80 pg/mL had higher rates of death, myocardial infarction, and CHF both at 30 days and at 10 months after presentation than patients whose BNP concentration was below 80 pg/mL. In this population of patients with ACS. BNP measurements within the first 72 hours after the onset of symptoms provide useful predictive information to aid in the risk stratification of patients with ACS.
Comparison to Predicate Methods
The device and test method described in the labeling are identical to the predicate device, the Triage® BNP Test. The antibodies used in the microplate assays and the Triage® BNP Test are identical, and both platforms utilize a sandwich ELISA assay. Furthermore, the same reagents used to calibrate the Triage® BNP Test also were used to calibrate the microplate assays. In this regard, the two assay formats are substantially equivalent.
The Dade Stratus Cardiac Troponin-I and Dade Dimension RxL Cardiac Troponin-I are used as predicate methods for the conceptual description of how a biochemical marker can be used to provide prognostic information to a physician. Although these predicate methods describe a different analyte, the description of how the test results should be interpreted with respect to the prognosis of the patient are substantially equivalent.
Conclusion
The use of the Triage® BNP Test to aid in the risk stratification of patients with ACS is substantially equivalent to the predicate methods.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a person with outstretched arms, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1 2002 ர்பட
Jeffery Dahlen, Ph.D. Principal Scientist Clinical Regulatory Affairs Biosite, Inc. 11030 Roselle Street San Diego, CA 92121
Re: K021317
Trade/Device Name: Triage® B-Type Natriuretic Peptide (BNP) Test Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: April 24, 2002 Received: April 25, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice reguirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and : additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K021317
Device Name: Triage® B-Type Natriuretic Peptide (BNP) Test
Indications For Use:
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is 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.
yan
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021312
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)