(117 days)
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No
The device description details a standard immunoassay using chemiluminescent technology and antibody binding to measure BNP levels. There is no mention of AI or ML in the intended use, device description, or the specific sections indicating their presence.
No
The device is an in vitro diagnostic assay used for the quantitative determination of BNP in human plasma, aiding in the diagnosis and assessment of heart failure. It is not designed to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and "as an aid in the diagnosis and assessment of the severity of heart failure."
No
The device description clearly outlines a hardware-based immunoassay system involving reagents, magnetic particles, incubation, washing, and a luminometer to measure chemiluminescence. This is 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 "For in vitro diagnostic use". It also describes the device's purpose as the "quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma," which is a biological sample analyzed outside of the body.
- Device Description: The description details a laboratory assay process involving the analysis of "Patient sample (calibrator or control materials)" using chemical reagents and a system to measure a signal. This is characteristic of an in vitro diagnostic test.
The information provided clearly indicates that this device is intended to be used in a laboratory setting to analyze biological samples (human plasma) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For ACS:180 BNP Assay: For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence 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. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.
For ADVIA Centaur BNP Assay: 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 and assessment of the severity of heart failure. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.
Product codes (comma separated list FDA assigned to the subject device)
NBC
Device Description
The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology, which use 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')2 fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse antihuman antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin Patient sample (calibrator or control materials) is incubated for 5 magnetic particles. minutes at 37°C with the 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 fuminometer. 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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
K0404-25
ACS:180® and ADVIA Centaur® BNP 510(k) ______________________________________________________________________________________________________________________________________________________________________________
Bayer Diagnostics JUN 1 4 2004 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 Healthcare - Diagnostics Division | |
| 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: | February 13, 2004 | |
| Device Information | ||
| Propriety Name: | ACS: 180® and ADVIA Centaur® B-Type Natriuretic | |
| Peptide (BNP) Assays | ||
| Common Name: | BNP assays | |
| Classification Name: | ||
| Class: | ||
| CFR: | ||
| Product Code: | B-type natriuretic peptide test systems | |
| II | ||
| 21 CFR 862.1117 | ||
| NBC |
3. Predicate Device Information
| Name: | ADVIA Centaur® B-Type Natriuretic Peptide (BNP) Assay |
|---|---|
| Manufacturer: | Bayer Healthcare - Diagnostics Division |
| 511 Benedict Ave. | |
| Tarrytown, N.Y. 10591 | |
| 510(k) Number: | K031038 |
1
4. Device Description
The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology, which use 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')2 fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse antihuman antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin Patient sample (calibrator or control materials) is incubated for 5 magnetic particles. minutes at 37°C with the 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 fuminometer. 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
ACS:180 BNP Assay
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peotide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence 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. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.
ADVIA Centaur BNP Assay
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peotide (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 and assessment of the severity of heart failure. This test, in coniunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.
6. Substantial Equivalence
The Bayer B-type Natriuretic Peptide (BNP) assays on the ACS:180® and ADVIA Centaur® are substantially equivalent to ADVIA Centaur® BNP assay. The ADVIA Centaur BNP Assay was cleared under K031038 on June 23, 2003; the ACS:180® BNP version has followed the new Replacement Reagent Policy guidance to allow its marketing under the same intended use.
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(a) Technological Characteristics
The following table compares the technology features of the current and proposed Bayer ADVIA Centaur and ACS: 180 BNP assays:
| Feature | Current Bayer ADVIA
Centaur® and ACS:180® BNP
Immunoassays | Proposed Bayer ADVIA
Centaur® and ACS:180® BNP
Immunoassays |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of B-
type Natriuretic Peptide | Same |
| Indication for Use | An aid in the diagnosis of heart
failure. | An aid in the diagnosis and
assessment of severity of heart
failure. To predict survival in
patients after myocardial
infarction, in conjunction with
other know risk factors. |
| Assay Principle | Chemiluminescence
immunoassay | Same |
| Traceability/Standardization | Reference standard –
synthetic human BNP (amino
acid 77 to 108) in buffer
based matrix. | Same |
| Calibration Interval | • After 28 days (ADVIA
Centaur), or 14 days
(ACS:180), when using the
same reagent lot
• With every new primary
reagent lot | Same |
| Sample Type | Human plasma using EDTA as
anticoagulant | Same |
| Sample Volume | 100 µL | Same |
| Calibrator | BNP Calibrator set (2 levels) | Same |
| Controls | BNP 1,2,3 Quality Control set | Same |
| Reagent Stability | Unopened
• Until the expiration date when
stored at 2-8°C
Onboard
• ADVIA Centaur: 41.6 days (or
60 days with the use of
version 3.0 software or
higher)
• ACS:180: 72 hours | Same |
| Instruments | • ADVIA Centaur and ACS:180
Systems, fully automated,
random-access immunoassay
analyzers | Same |
| Measuring Range | • ADVIA Centaur: