(120 days)
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No
The description details a standard automated immunoassay technique (ELFA) and mentions calculations based on stored calibration curves, not AI/ML algorithms. There is no mention of AI, ML, or related terms in the document.
No
This device is an in vitro diagnostic test used for aid in the diagnosis of suspected congestive heart failure by measuring a biomarker; it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure." This indicates its role in the diagnostic process.
No
The device is an in vitro diagnostic (IVD) assay that utilizes physical reagents (SPR, reagent strips) and an automated instrument (VIDAS) to perform the test and calculate results. While software is involved in the automation and calculation, it is integral to a hardware and reagent-based system, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma... using the ELFA... technique." This involves testing biological samples in vitro (outside the body).
- Aid in Diagnosis: The test is used "as an aid in the diagnosis of suspected congestive heart failure." This is a common purpose for IVD devices, providing information to help clinicians make a diagnosis.
- Device Description: The description details the use of "human serum or plasma," "reagent strips," and an "automated quantitative test" performed on an instrument. These are all characteristics of IVD devices.
- Performance Studies: The performance studies evaluate the test's ability to distinguish between patients with and without CHF based on the results obtained from testing biological samples. This is typical for validating the clinical performance of an IVD.
N/A
Intended Use / Indications for Use
The VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
Product codes
NBC
Device Description
The VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail in the 510(k) and in the package insert.
All of the assay steps are performed automatically by the VIDAS instrument. The sample is transferred into the well containing anti-NT-proBNP antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the VIDAS instrument in relation to two calibration curves corresponding to the two detection steps stored in memory, and then printed out.
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
Prescription Use
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
Clinical Comparison:
Reference Group (without CHF):
Number of patients: 411 patients
Study Site(s): US and Europe
Results:
%
§ 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
FEB 2 9 2008
510(k) SUMMARY
VIDAS® NT-proBNP Assay
A. Submitter Information
Submitter's Name: | bioMérieux, Inc. |
---|---|
Address: | 595 Anglum Road |
Hazelwood, MO 63042 | |
Contact Person: | Nikita S. Mapp |
Phone Number: | 314-731-7474 |
Fax Number: | 314-731-8689 |
Date of Preparation: | October 2007 (revised February 2008). |
Device Name | VIDAS® NT-proBNP |
Trade Name: | VIDAS® NT-proBNP |
Common Name: | Endotoxin Assay |
Classification Name: | 21 CFR 862.1117 Product Code NBC |
B-type natriuretic peptide test system |
C. Predicate Device Name
Trade Name:
B.
Elecsys proBNP Assay
D. Device Description
The VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail in the 510(k) and in the package insert.
All of the assay steps are performed automatically by the VIDAS instrument. The sample is transferred into the well containing anti-NT-proBNP antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of
1
the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the VIDAS instrument in relation to two calibration curves corresponding to the two detection steps stored in memory, and then printed out.
E. Intended Use
The VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the assays is presented in the table below.
| Item | Device
[VIDAS NT-proBNP] | Predicate
[Elecsys proBNP] | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| General Comparison | | | |
| Intended Use | Quantitative determination of N terminal
fragment of B-type natriuretic peptide in
human serum or plasma (lithium heparin).
The VIDAS NT-proBNP test is used as an
aid in the diagnosis of suspected congestive
heart failure. | Same as initial claim [K022516].
Roche obtained additional claims via
other 510(k)s, "risk stratification" and
"risk assessment " which bioMerieux is
not pursuing at this time. | |
| Specimen | Human serum or plasma | Same | |
| Analyte | Measures NT-proBNP | Same | |
| Antibody | Anti-NT-proBNP antibody (polyclonal
sheep) | Same | |
| Assay Principle | Immunoassay based on sandwich principle | Same | |
| Automated | Automated assay | Same | |
| Assay Technique | Enzyme-Linked Fluorescent Assay (ELFA) | Electrochemiluminescent assay | |
| Sample Volume | 200 μl | 20 μl | |
| Assay Time | ~20 minutes | 18 minutes | |
| Traceability/
Standardization | Traceable to proBNP Roche | Reference standard - purified
synthetic NTG-proBNP (1-76) in
human serum matrix | |
| Measurement range | 20-25,000 pg/mL | 5-35,000 pg/mL | |
| Test | Device
[VIDAS NT-proBNP] | Predicate
[Elecsys proBNP] | |
| Non-clinical (Analytical) Comparison | | | |
| Matrix Comparison | Serum similar to Plasma
For patient follow-up, assays must be performed
on the same type of sample tube. | Same | |
| Precision | 5 samples tested in duplicate in 40 different
runs (2 runs per day)
repeatability (intra-run): 1.5 – 2.8 %CV
inter-site: 3.4 – 5.1 %CV
inter-lot: 3.5 – 8.4 %CV | 4 samples tested in 6 times daily for
10 days
total precision: 2.2 – 3.2%CV
within run precision: 1.8 – 2.7%CV | |
| Detection Limits | in vitro | No interference found on commonly
used pharmaceuticals | |
| Hook Effect | No hook effect found up to concentrations
of 500,000 pg/mL | No hook effect found up to
concentrations of 300,000 pg/mL | |
| Clinical Comparison | | | |
| Cut-off | 125 pg/mL for patients