(83 days)
No
The device description details a standard immunoassay technology and there is no mention of AI or ML in the summary.
No
This device is for in vitro diagnostic use, meaning it measures a substance in a sample (plasma) to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use in the quantitative determination of Btype Natriuretic Peptide (BNP) in human plasma… This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure." The phrase "aid in the diagnosis of heart failure" directly indicates its diagnostic purpose.
No
The device description clearly outlines a complex immunoassay process involving reagents, antibodies, magnetic particles, incubation, washing, and measurement using a luminometer. This indicates a significant hardware component (the ADVIA Centaur® System) is integral to the device's function, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use in the quantitative determination of Btype Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System."
This statement clearly indicates that the device is intended for use outside of the body (in vitro) to diagnose a condition (heart failure) by analyzing a human sample (plasma).
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure. This assay is not intended for use on any other system.
Product codes (comma separated list FDA assigned to the subject device)
NBC, JIT, JJX
Device Description
The ADVIA® Centaur® BNP assay is a fully automated two-site sandwich immunoassay using direct chemiluminescent technology, which uses constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')> fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Lite Reagent that contains the tracer antibody conjugate. Subsequently, Solid Phase reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a luminometer. Samples with low BNP levels will have a minimum amount of bound AE label, while samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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)
A paired comparison was performed at 2 clinical trial sites to assess the relationship of the ADVIA Centaur BNP assay to the predicate device. A total of 167 patients with heart failure (HF; clinical diagnoses of Class I – IV) and 20 individuals without heart failure (non-HF) were compared for both analytical and clinical agreement at a decision threshold of 100 pg/mL.
Analytical Comparison - ADVIA Centaur vs. Predicate Device
Sample size: 187 (167 cases, 20 controls)
% Analytical Agreement: 94.7 % (177/187), 95% Confidence Interval: 90.4% to 97.4%
Clinical Agreement - ADVIA Centaur BNP
Sample size: 187 (167 persons with HF, 20 persons without HF)
% Clinical Agreement: 87.2% (163/187), 95% Confidence Interval: 81.5% to 91.6%
Clinical Agreement - Predicate Device
Sample size: 187 (167 persons with HF, 20 persons without HF)
% Clinical Agreement: 86.1% (161/187), 95% Confidence Interval: 80.3% to 90.7%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Agreement - ADVIA Centaur BNP:
% Sensitivity: 87.4% (146/167)
% Specificity: 85.0% (17/20)
Clinical Agreement - Predicate Device:
% Sensitivity: 87.4% (146/167)
% Specificity: 75.0% (15/20)
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.
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.”
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Bayer Diagnostics ADVIA Centaur BNP Assay
Summary of Safety and Effectiveness
This Summary of Safety and Effectiveness has been prepared in accordance with the requirements of 21 CFR 807.92, to provide sufficient information to understand the basis for a determination of substantial equivalence.
| 1. Submitter Information | |
|---|---|
| Contact Person: | Kenneth T. Edds, Ph.D. |
| Address: | Bayer Diagnostics Corporation |
| 511 Benedict Ave. | |
| Tarrytown, N.Y. 10591 | |
| Phone: (914) 524 2446 | |
| Fax: (914) 524 2500 | |
| e-mail: ken.edds.b@bayer.com | |
| Date Summary Prepared: | March 28, 2003 |
2. Device Information
| Propriety Name: | ADVIA Centaur® B-Type Natriuretic Peptide (BNP) Assay |
|---|---|
| Common Name: | BNP assay |
| Classification Name: | B-type natriuretic peptide test system |
| Class: | II |
| CFR: | 21 CFR 862.1117 |
| Product Code: | NBC, JIT, JJX |
3. Predicate Device Information
| Name: | Triage BNP Test |
|---|---|
| Manufacturer: | |
| Manufactured by: | Biosite Diagnostics Incorporated |
| 11030 Roselle Street | |
| San Diego, California 92121, USA | |
| 510(k) Number: | K003475/K010266 |
1
4. Device Description
The ADVIA® Centaur® BNP assay is a fully automated two-site sandwich immunoassay using direct chemiluminescent technology, which uses constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')> fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Lite Reagent that contains the tracer antibody conjugate. Subsequently, Solid Phase reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a luminometer. Samples with low BNP levels will have a minimum amount of bound AE label, while samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the amount of relative light units (RLUs) detected by the system.
5. Statement of Intended Use
The Bayer ADVIA® Centaur® BNP assay is an in vitro immunoassay for the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA® Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure.
6. Substantial Equivalence
The Bayer ADVIA Centaur BNP assay is substantially equivalent to other devices legally marketed in the United States. The ADVIA Centaur BNP assay is similar to the Biosite Triage BNP predicate device cleared under K010266. Both products are two-site immunoassays, which are intended for use in the quantitative determination of the B-type Natriuretic Peptide.
(a) Technological Characteristics
The following table compares the technology features of the Bayer ADVIA Centaur BNP assay with the Biosite Triage BNP predicate device:
| Feature | Bayer ADVIA Centaur® BNP
Immunoassay | Biosite Triage® BNP Test
(Predicate Device) |
|------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of B-
type Natriuretic Peptide | Measurement of B-type
Natriuretic Peptide |
| Indication for Use | An aid in the diagnosis of heart
failure. | An aid in the diagnosis of
congestive heart failure. |
| Assay Principle | Chemiluminescence
immunoassay | Fluorescence immunoassay |
| Traceability/Standardization | • Reference standard - synthetic
human BNP (amino acid 77 to
108) in buffer based matrix. | Purified protein preparation of
BNP based on the mass
(concentration) of analyte
present in EDTA plasma. |
2
| Feature | Bayer ADVIA Centaur® BNP
Immunoassay | Biosite Triage® BNP Test
(Predicate Device) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Calibration Interval | • After 28 days when using the
same reagent lot
• With every new primary
reagent lot | Each kit |
| Sample Type | Human plasma using EDTA as
anticoagulant | Human whole blood and plasma
using EDTA as anticoagulant |
| Sample Volume | 100 µL | ~200 µL |
| Calibrator | BNP Calibrator set (2 levels) | Electronic code chip |
| Controls | BNP 1,2,3 Quality Control set | Triage® BNP Controls |
| Reagent Stability | Unopened
• Until the expiration date when
stored at 2-8°C
Onboard
• 41.6 days (or 60 days with the
use of version 3.0 software or
higher) | • Until the expiration date when
stored at 2-8°C
• 14 days at room temperature |
| Instrument | ADVIA Centaur System, a fully
automated, random-access
immunoassay analyzer | Triage® Meter |
| Measuring Range | 5000 pg/mL), the test should be interpreted as having a positive result because the BNP concentration is significantly elevated. |
| Limitations/Warning/Precautions | This test has been evaluated with plasma using EDTA as the anticoagulant. Serum, | This test has been evaluated with whole blood and plasma using EDTA as the |
3
| Feature | Bayer ADVIA Centaur® BNP
Immunoassay | Biosite Triage® BNP Test
(Predicate Device) |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | sodium citrate, lithium heparin
and sodium fluoride sample
tubes have also been tested
and are not recommended.
• No interference from
hemoglobin up to 1000 mg/dL
• No interference from
triglycerides up to 800 mg/dL
• No interference from
cholesterol up to 1000 mg/dL
• No interference from urea up
to 200 mg/dL
• No interference from
creatinine up to 2.5 mg/dL
• No interference from
unconjugated bilirubin up to
25 mg/dL
• No interference from
conjugated bilirubin up to
25 mg/dL
• No interference from human
IgG up to 5.3 g/dL
• No interference from 55
commonly used
pharmaceutical drugs.
• Results should always be
assessed in conjunction with
the patient's medical history,
clinical evaluation and other
diagnostic procedures. | anticoagulant. Serum and
blood or plasma specimens
obtained using other
anticoagulants (e.g. heparin
or citrate) have not been
evaluated and should not be
used.
• No interference from
hemoglobin up to
10000 mg/dL
• Severely hemolyzed
specimens should be avoided
• No interference from
triglycerides up to 1000 mg/dL
• No interference from
cholesterol up to 1000 mg/dL
• No interference from bilirubin
up to 20 mg/dL
• No interference from 55
commonly used
pharmaceutical drugs.
• Results should be evaluated
in the context of all the clinical
and laboratory data available. |
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(c) Analytical Comparison and Clinical Agreement
A paired comparison was performed at 2 clinical trial sites to assess the relationship of the ADVIA Centaur BNP assay to the predicate device. A total of 167 patients with heart failure (HF; clinical diagnoses of Class I – IV) and 20 individuals without heart failure (non-HF) were compared for both analytical and clinical agreement at a decision threshold of 100 pg/mL.
Analytical Comparison - ADVIA Centaur vs. Predicate Device
| Predicate Device | ||||
|---|---|---|---|---|
| ≥ 100 pg/mL |