(28 days)
ADVIA Centaur BNP Assay
ADVIA IMS® System
No
The device description details a standard immunoassay using magnetic separation and luminescence detection. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on analytical performance metrics typical of in vitro diagnostic assays, not AI/ML model evaluation.
No
This device is an in vitro diagnostic (IVD) immunoassay designed for the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma, which is used as an aid in diagnosis and assessment of heart failure. It does not directly treat or prevent a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the method is "for in vitro diagnostic use" and "is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure." The "Device Description" also refers to it as an "in vitro immunoassay."
No
The device description clearly outlines a heterogeneous sandwich immunoassay using magnetic separation, reagents, enzymes, and luminescence measurement, indicating a hardware-dependent in vitro diagnostic system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The Bayer ADVIA IMS BNP method is for in vitro diagnostic use". It also describes the intended use as the quantitative determination of BNP in human plasma to aid in the diagnosis and assessment of heart failure and predict outcomes in patients with acute coronary syndromes. This aligns perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details an "in vitro immunoassay" that measures BNP in human EDTA plasma. It describes the reagents and the process of the assay, which is performed outside of the body using a biological sample.
- Performance Studies: The performance studies described (Imprecision, Correlation, Interfering substances, Analytical Range, Minimum Detectable Concentration, Expected Results) are typical studies conducted to validate the performance of an in vitro diagnostic assay.
- Predicate Device: The mention of a "Predicate Device(s)" which is the "ADVIA Centaur BNP Assay" further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
Therefore, based on the provided information, the Bayer ADVIA IMS BNP method is clearly an In Vitro Diagnostic device.
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 IMS® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
Product codes
NBC
Device Description
The ADVIA IMS BNP Assay is an in vitro immunoassay intended for the quantitative measurement of b-type natriuretic peptide (BNP) in human EDTA plasma covering the analytical range of 10 to approximately 6,000 pg/mL. The assay is a heterogeneous sandwich immunoassay using magnetic separation. Reagony a a freel genedus monoclonal antibody to BNP labeled with FITC and Reagent 2 (R2) contains the second monoclonal antibody to BNP (F(ab)2) conjugated to the enzyme /kaline phosphatase (ALP). The monoclonal antibodies used in the ADVIA IMS BNP assay are identical to those used in the ADVIA Centaur assay. The sandwich complex formed by the modite and the antibody conjugates is captured by the magnetic particles so that the BNP concentration in the sample can be measured in terms of enzyme activity. The substrate used for this assay is a dioxetane phosphate derivative, which is dephosphorylated by ALP resulting in photon emission. Luminescence is measured by a photomultiplier tube. The dose response curve is proportional to the analyte concentration in sample
The Centaur BNP Master Curve Material (MCM) (part number 02815905) will be used as the calibrators (six levels) for the ADVIA IMS BNP assay. The controls used in the ADVIA IMS BNP assay, QC BNP 1, 2, 3 (REF 02817045), are existing Bayer Centair products consisting of three levels of lyophilized controls. The controls contain various concentrations of BNP in buffered sodium caseinate with preservative.
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
- Imprecision:
- ADVIA IMS: Level 71 pg/mL (Total CV 4.1%), Level 716 pg/mL (Total CV 1.9%), Level 2660 pg/mL (Total CV 1.8%)
- ADVIA Centaur: Level 48.5 pg/mL (Total CV 3.5%), Level 458 pg/mL (Total CV 2.8%), Level 1736 pg/mL (Total CV 2.9%)
- Correlation:
- Specimen type: EDTA Plasma
- Comparison System (X): ADVIA Centaur
- N: 360
- Regression Equation: Y = 0.990 * X + 4.37 (Y= ADVIA IMS, X= comparison system)
- Syx: 111.7 pg/mL
- R: 0.992
- Sample Range: 4 to 4531 pg/mL
- Interfering substances: Performance evaluated for Albumin, Bilirubin, Cholesterol, Creatinine, Hemoglobin, Triglyceride, Urea Nitrogen, and IgG at specified concentrations with recovery percentages.
- Analytical Range: 4 pg/mL (1.1 pmol/L) to calibrator level 6 concentration (about 6000 pg/mL or 1728 pmol/L).
- Minimum Detectable Concentration: ADVIA IMS BNP (4 pg/mL), ADVIA Centaur BNP (2 pg/mL).
- Expected Results: Determined from clinical studies performed for the predicate ADVIA Centaur BNP Test.
- Reference Group (individuals without heart failure): 1521 individuals (785 women and 736 men), including apparently healthy individuals and individuals with hypertension, diabetes, renal insufficiency, and chronic obstructive pulmonary disease. The decision threshold was 100 pg/mL, resulting in a general specificity of greater than 97%.
- Patients with Heart Failure: 722 patients (264 women and 458 men) diagnosed with heart failure, categorized by NYHA Functional Class (I, II, III, IV). Mean, SD, Median, 5th percentile, 95th percentile, % > 100 pg/mL, Minimum, Maximum, and N are provided for each class and overall.
Key Metrics
- Imprecision (CV%):
- ADVIA IMS: 4.1% (Level 71), 1.9% (Level 716), 1.8% (Level 2660)
- ADVIA Centaur: 3.5% (Level 48.5), 2.8% (Level 458), 2.9% (Level 1736)
- Correlation Coefficient (R): 0.992
- Specificity (for Reference Group): greater than 97 % (at 100 pg/mL decision threshold)
Predicate Device(s)
ADVIA Centaur BNP Assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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JUN 1 3 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BNP Assay for Bayer ADVIA® Integrated Modular System (IMS)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K051265
June 6, 2005
1. Submitter's name, address and telephone number:
Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC A subsidiary of Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591 TEL: 914-524-2531 FAX: 914-524-2500 Email: andres holle b@bayer.com
2. Name of the device:
| a) | Classification Names: B-type natriuretic peptide test systems, §862.1117 |
|---|---|
| Classification: | Class II |
| Product Code: | NBC |
- b) Common name: BNP assays
- c) Proprietary name: ADVIA Immuno Modular System (IMS)® B-Type Natriuretic Peptide (BNP) Assay
d) The device:
| Product Name | Reagent Part
/ BAN Number | Calibrator Part
/ BAN Number |
|---------------------|--------------------------------|-----------------------------------|
| ADVIA IMS BNP Assay | 0154537
(100 tests) | 00155177 |
3. Predicate Device:
| Product Name | Reagent Part # | Master Curve
Material Part # |
|-------------------------|------------------------------------------------------------|---------------------------------|
| ADVIA Centaur BNP Assay | REF 02816634
(500 tests)
REF 02816138
(100 tests) | REF 02815905 |
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4. Description of the device:
The ADVIA IMS BNP Assay is an in vitro immunoassay intended for the quantitative measurement of b-type natriuretic peptide (BNP) in human EDTA plasma covering the analytical range of 10 to approximately 6,000 pg/mL. The assay is a heterogeneous sandwich immunoassay using magnetic separation. Reagony a a freel genedus monoclonal antibody to BNP labeled with FITC and Reagent 2 (R2) contains the second monoclonal antibody to BNP (F(ab)2) conjugated to the enzyme /kaline phosphatase (ALP). The monoclonal antibodies used in the ADVIA IMS BNP assay are identical to those used in the ADVIA Centaur assay. The sandwich complex formed by the modite and the antibody conjugates is captured by the magnetic particles so that the BNP concentration in the sample can be measured in terms of enzyme activity. The substrate used for this assay is a dioxetane phosphate derivative, which is dephosphorylated by ALP resulting in photon emission. Luminescence is measured by a photomultiplier tube. The dose response curve is proportional to the analyte concentration in sample
The Centaur BNP Master Curve Material (MCM) (part number 02815905) will be used as the calibrators (six levels) for the ADVIA IMS BNP assay. The controls used in the ADVIA IMS BNP assay, QC BNP 1, 2, 3 (REF 02817045), are existing Bayer Centair products consisting of three levels of lyophilized controls. The controls contain various concentrations of BNP in buffered sodium caseinate with preservative.
5. Intended Use
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA IMS® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
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| | ADVIA IMS BNP assay | ADVIA Centaur BNP assay
(predicate device) |
|---------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | Same | Same |
| Summary | Same | Same |
| Principle | Heterogeneous Sandwich
Magnetic Separation Assay | Heterogeneous Sandwich
Magnetic Separation Assay |
| Reagents | Two liquid reagents contained
in system specific packaging | Two liquid reagents contained
in system specific packaging |
| Storage | 2-8 °C | 2-8 °C |
| Stability | Same | Same |
| Precautions | Same | Similar |
| Indications of
Deterioration | Same | Same |
| Performance
Characteristics | Same | Same |
| Limitations | Same | Same |
| Parameters | Multi-point calibration,
sandwich immunoassay and
system specific parameters | Multi-point calibration,
sandwich immunoassay and
system specific parameters |
6. Similarities and Differences between ADVIA® IMS™ BNP assay and Bayer Centaur® BNP assay:
7. Performance summary:
a) Imprecision:
| ADVIA IMS | ADVIA Centaur | |||
|---|---|---|---|---|
| Level | ||||
| Total | ||||
| (pg/mL) | ||||
| CV(%) | Level | |||
| (pg/mL) | Total | |||
| CV(%) | ||||
| 71 | 4.1 | 48.5 | 3.5 | |
| 716 | 1.9 | 458 | 2.8 | |
| 2660 | 1.8 | 1736 | 2.9 |
b) Correlation:
| Specimen type | Comparison
System (X) | N | Regression
Equation | Syx
(pg/mL) | R | Sample
Range
(pg/mL) |
|---------------|--------------------------|-----|------------------------|----------------|-------|----------------------------|
| EDTA Plasma | ADVIA
Centaur | 360 | $0.990 * X + 4.37$ | 111.7 | 0.992 | 4 to 4531 |
(Y= ADVIA IMS, X= comparison system)
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c) Interfering substances:
| Interference | Interference Conc.
mg/dL | Recovery (pg/mL) | | %
Deviation |
|---------------|-----------------------------|------------------|----------|----------------|
| | | Expected | Observed | |
| Albumin | 7,000 | 145.3 | 131.5 | -9.46 |
| | | 407.5 | 377.9 | -7.27 |
| Bilirubin | 25 | 79.4 | 80.6 | 1.50 |
| | | 366.1 | 356.4 | -2.65 |
| Cholesterol | 1,000 | 133.8 | 139.5 | 4.26 |
| | | 352.8 | 383.6 | 8.73 |
| Creatinine | 2.5 | 99.2 | 100.0 | 0.76 |
| | | 427.0 | 419.0 | -1.87 |
| Hemoglobin | 750 | 86.7 | 78.3 | -9.68 |
| | | 402.3 | 366.7 | -8.86 |
| Triglyceride | 800 | 86.2 | 83.4 | -3.19 |
| | | 389.4 | 384.3 | -1.32 |
| Urea Nitrogen | 200 | 87.7 | 88.9 | 1.34 |
| | | 380.2 | 382.0 | 0.48 |
| IgG | 4,600 | 129.3 | 141.2 | 9.15 |
| | | 398.7 | 435.8 | 9.30 |
d). Analytical Range:
4 pg/mL (1.1 pmol/L) to calibrator level 6 concentration (about 6000 pg/mL or 1728 pmol/L)
e) Minimum Detectable Concentration:
| ADVIA IMS BNP (pg/mL) | ADVIA Centaur BNP (pg/mL) |
|---|---|
| 4 | 2 |
f) Expected Results:
.
The expected values were determined from clinical studies performed for the predicate ADVIA Centaur BNP Test and results of the studies are included in the labeling for the ADVIA IMS BNP assay.
BNP concentrations in the Reference Group are shown in the tables below. The decision threshold was determined by the 95% confidence limit of BNP in the Reference population. The most appropriate decision threshold apparent from these distributions is 100 pg/mL. This BNP value translates into a general specificity of the test of greater than 97 %.
Reference Group
To establish the expected results, the circulating BNP concentration was determined from 1521 individuals without heart failure (785 women and 736 men). This population included apparently healthy individuals and individuals with hypertension, diabetes, renal insufficiency, and chronic obstructive pulmonary disease. The
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descriptive statistics for BNP concentrations in the population without heart failure are shown in the following tables. These values are representative of the results obtained from clinical studies.
| All | Age Group | |||||
|---|---|---|---|---|---|---|
| All | 100 pg/mL | 72.6 | 43.1 | 58.7 | 82.0 | |
| Minimum, pg/mL | 100 pg/mL | 72.9 | 44.7 | 61.3 | 81.4 | 93.9 |
| Minimum, pg/mL | 100 pg/mL | 72.0 | 40.0 | 54.3 | 83.2 | 98.1 |
| Minimum, pg/mL |