(151 days)
Not Found
No
The device description details a standard immunoassay technology and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is an in vitro diagnostic (IVD) assay used for the quantitative determination of BNP in human plasma, which aids in the diagnosis and assessment of heart failure, and is not a device used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and that the assay is "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, antibodies, magnetic particles, and a luminometer to measure a chemiluminescent signal. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Purpose: The device is intended to measure B-type Natriuretic Peptide (BNP) in human plasma to aid in the diagnosis and assessment of heart failure and predict outcomes in patients with acute coronary syndromes. This is a diagnostic purpose performed outside of the living body (in vitro).
- Sample Type: The device analyzes human plasma, which is a biological sample taken from the body.
- Technology: The device uses immunoassay technology to detect and quantify a specific analyte (BNP) in the sample.
All of these characteristics align with the definition of 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 Centaur® 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.
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. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used 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 ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology. The first antibody, in the Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP. The second antibody, in the BNP Reagent, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Sample (calibrators or control materials) is incubated for 5 minutes at 37°C with the Reagent. Subsequently, Solid Phase Reagent to added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. Confident. The immuno-complex signal is measured in a luminometer. The chemiluminescence of the 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 Samples with light lovely the amount of BNP present in the patient sample and the relationing 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.”
0
Bayer Diagnostics ADVIA Centaur BNP Assay
APR 2 2 2005
Summary of Safety and Effectiveness
This Summary of Safety and Effectiveness has been prepared in accordance with the Inis Summary of Sufey and "Effectives" has "Securition to understand the basis for a determination of substantial equivalence.
| 1. Submitter Information | |
|---|---|
| Contact Person: | Carol Bianca |
| Address: | Bayer Healthcare - Diagnostics Division |
| 511 Benedict Ave. | |
| Tarrytown, N.Y. 10591 | |
| Phone: (914) 524 2531 | |
| Fax: (914) 524 2500 | |
| e-mail: carol.bianca.b@bayer.com | |
| Date Summary Prepared: | October 18, 2004 |
| 2. Device Information | |
| Propriety Name: | ACS:180® and ADVIA Centaur® B-Type Natriuretic |
| Peptide (BNP) Assays | |
| Common Name: | BNP assays |
| Classification Name: | B-type natriuretic peptide test systems |
| Class: | -II |
| CFR: | 21 CFR 862.1117 |
| Product Code: | 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) Numbers: | K031038; K040425 |
1
4. Device Description
The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich The ACS. Too and ADVIN Ochtair Dr. Which use constant amounts of Immundassays using direct chemich.noosent issume is in the Reagent, is an acridinium ester two monoclonal antioodies: The first artissoft in the ting structure labeled monoconal mouse and haman is a biotinylated monoclonal mouse antiof BNP. The second antibody, in the C-terminal portion of BNP, which is coupled to streptavidin numan antibody specific to the O terminal portion or control materials) is incubated for 5 mightene particles. Thaten comple (cambreton the tracer antibody conjugate. minutes at 37 0 with the ERS Reagent is added and incubated for 2.5 minutes at 37°C. An Subsequently, Solla Frase reagont to added in the sample and the two antibody infinuno-complex is Tormed bothern the unbound antibody conjugates are washed away. Confider . Following noducal in muno-complex signal is measured in a luminometer. The Gremiumninescents of the 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 Samples with light lovely the amount of BNP present in the patient sample and the relationing light units (RLUs) detected by the system.
5. Statement of Intended Use
ACS:180 BNP Assay
ACS.100 DNr 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 (ONY / In harian plasma comp trurement of plasma BNP as an aid in the diagnosis and assay is indicated for the modularentailure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict (AGO), this test, in ochjarieter likelihood of future heart failure. 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 Peptide I or in human plasma using the ADVIA Centaur® System. This assay is indicated for the (DNP) in haman plasma BNP as an aid in the diagnosis and assessment of the severity of measurement of plasma bry. "Co ar aronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the other known i how labor failure. 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 The Bayer e substantially equivalent to ADVIA Centaur® BNP assay. The ADVIA Centaur® are Substantially oquiralerr K031038 on June 23, 2003, as an aid in diagnosis Centail bril Assay was sloured the version has followed the new Replacement Reagent of heart railure. The AOC.100 - BRICA of the same intended use. The ADVIA Centaur r only guidance to allow his were cleared under K040425 on June 14, 2004, for the and AOS: 100 En. as a for use, in conjunction with other known risk factors, to predict survival in patients after myocardial infarction.
2
(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 and
assessment of the severity of
heart failure. Can also be used,
in conjunction with other known
risk factors, to predict survival in
patients after myocardial
infarction. | An aid in the diagnosis and
assessment of the severity of
heart failure. Can also be used,
in conjunction with other known
risk factors, to predict survival as
well as to predict the likelihood of
future heart failure in patients
with acute coronary syndromes. |
| 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 42 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 | • 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: 10(t) prematics is substantially equivalent (for the indications felerenced above and nave determined and marketed predicate devices marketed in interstate for use stated in the cherosure) to regars actment date of the Medical Device Amendments, or to commence prof to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recides in assee approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not required to the general controls provisions of the Act. The Tou may, increrore, market the device, octorements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may be subject to such additional controllations (CFR), Parts 800 to 895. In addition, FDA can be found in Thee 21, Courseling your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri of issualites wour device complies with other requirements of the Act that FDA has made a decemmanding administered by other Federal agencies. You must of any I cuchai statutes and regulations, but not limited to: registration and listing (21 Comply with the Are Free Frequirements 801 and 809); and good manufacturing practice CFR Part 807), fabening (21 CF RT + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
6
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maining of substantial equivalence of your device to a legally premarket notification: "The PD's in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific infortion and advertising of your device, please contact the Office of In of quotions on the promie Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other butter gear. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K043228
Device Name: Bayer Diagnostics ADVIA Centaur® BNP Assay
Indications For Use:
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide For in ville diagnostic use in the quantica. Contaur System. This assay is indicated for (BNP) in numan plasma doling the AIS AIS AIR PERSENTIAN as and assessment of the the measurement of plasma BNF acute coronary syndromes (ACS), this test, in sevelly of healt fallure. In pations with as a see to predict survival as well as well as well as well as conjunction with other known hist factors, can also assay is not intended for use on any other system.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety Page 1 of 2 __________________________________________________________________________________________________________________________________________________________________
$1000 K043228
8
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K043228
Device Name: Bayer Diagnostics ACS:180® BNP Assay
Indications For Use:
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide For in virro diagnostic use in the quantitative docommation on a promotive scence System. (BNP) in human plasma using the NOC. 100 - Altema BNP as an aid in the diagnosis This assay is Indicated for the mo mo mo and failure. In patients with acute coronary and assessment of the seventy of hourthaller known risk factors, can also be syndromes (ACO), this test, in onlyandlier will be likelihood of future heart failure. This assay is not intended for use on any other system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Døvice Evaluation and Safety
2 Page 2 of