(191 days)
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No
The summary describes a quantitative immunoassay for measuring BNP and does not mention any AI/ML components or image processing.
No
The device is described as an "in vitro quantitative measurement" and an "aid in the diagnosis and assessment" of conditions, which indicates it is used for diagnostic purposes rather than therapy.
Yes
The 'Intended Use' section states that the device is "used as an aid in the diagnosis and assessment of severity of congestive heart failure" and "for the risk stratification of patients with acute coronary syndromes." This directly indicates a diagnostic purpose.
No
The device description explicitly states it is a "Triage® BNP Test" intended for use with a "Triage® Meter" and measures BNP in biological specimens. This indicates a physical test kit and a meter (hardware) are involved, not just software.
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 (BNP) in human capillary whole blood, venous whole blood or plasma specimens". The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body, which is the defining characteristic of an IVD.
- Device Description: The "Device Description" section reiterates the same intended use, further confirming its in vitro nature.
- Specimen Type: The test uses human biological specimens (whole blood and plasma), which are typical for IVD tests.
- Purpose: The test is used as an aid in diagnosis and assessment of severity of a medical condition (congestive heart failure) and for risk stratification, which are common applications for IVD devices.
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 capillary whole blood, venous 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 (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
Product codes
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 capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant.
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
A comparison between Triage® BNP Test results obtained from capillary whole blood specimens and venous whole blood specimens from the same individual was performed. A total of 67 paired samples were evaluated. All results were blinded.
43.3% of the capillary blood samples were obtained using a single finger stick, 35.8% of the samples were obtained using two finger sticks, and 20.9% of the samples were obtained using three or more finger sticks. Data were analyzed by linear regression and potential differences in the data sets were evaluated using the Wilcoxon Signed Ranks test, with p
§ 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
JAN 2 8 2004
Biosite Incorporated Triage® B-Type Natriuretic Peptide (BNP) Test
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | January 13, 2003 |
|---|---|
| Submitter: | Biosite Incorporated |
| Address: | 11030 Roselle Street |
| San Diego, CA 92121 | |
| Phone (858) 455-4808 | |
| Fax (858) 535-8350 | |
| Contact: | Jeffrey R. Dahlen, Ph.D. |
| Clinical & Regulatory Affairs | |
| Principal Scientist | |
| Device: | Trade/Proprietary Name: |
| Triage® B-Type Natriuretic Peptide (BNP) Test | |
| Common/Usual Name: | |
| BNP Test | |
| Classification: | Office of In Vitro Diagnostic Device Evaluation and |
| Safety (OIVD) | |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - NBC | |
| Predicate Devices: | Triage® B-Type Natriuretic Peptide (BNP) Test |
| 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 capillary whole blood, venous 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 (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
1
Assessment of Performance:
A comparison between Triage® BNP Test results obtained from capillary whole blood specimens and venous whole blood specimens from the same individual was performed. A total of 67 paired samples were evaluated. All results were blinded.
43.3% of the capillary blood samples were obtained using a single finger stick, 35.8% of the samples were obtained using two finger sticks, and 20.9% of the samples were obtained using three or more finger sticks. Data were analyzed by linear regression and potential differences in the data sets were evaluated using the Wilcoxon Signed Ranks test, with p