(81 days)
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No
The description details a standard enzyme immunoassay based on chemical reactions and optical measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic assay used to measure NT-proBNP in human plasma, aiding in diagnosis and assessment of heart conditions, but it does not treat or directly intervene in a patient's health.
Yes
The "Intended Use / Indications for Use" section explicitly states that the method is an "in vitro diagnostic assay" and that measurements are "used as an aid in the diagnosis and assessment of severity" for certain conditions.
No
The device is an in vitro diagnostic assay consisting of reagents and a cartridge for use on a clinical chemistry system. It involves chemical reactions and physical separation steps, clearly indicating it is a hardware-based device with chemical components, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the method is an "in vitro diagnostic assay."
- Device Description: The "Device Description" also refers to the method as an "in vitro diagnostic test."
- Function: The device is designed to analyze human plasma samples to measure a specific analyte (NT-proBNP) to aid in the diagnosis and assessment of medical conditions (congestive heart failure, acute coronary syndrome). This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dimension® PBNP Flex® method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity of individuals suspected of having congestive heart failure and for risk stratification of patients with acute coronary syndrome and heart failure.
Product codes (comma separated list FDA assigned to the subject device)
NBC
Device Description
The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The PBNP method is a one step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with polyclonal antibodies which recognize epitopes located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)] labeled polyclonal antibody specific for a second independent epitope on NT-proBNP, to form a particle/NT-proBNP/conjugate sandwich. Unbound conjugate is removed by magnetic separation and washing. After separation and washing, the particle/NT-proBNP/conjugate sandwich is transferred to the cuvette where the sandwich-bound ALP triggers an amplification cascade * ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to produce FAD. FAD binds to apo D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase produces multiple molecules of hydrogen peroxide (H2O2). H2O2 in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510 nm. The color change measured is directly proportional to the concentration of proBNP present in the patient sample.
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.
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.”
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NOV 1 9 2004
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | August 27, 2004 |
| Name of Product(s): | Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method |
| FDA Classification Name(s): | B-type natriuretic peptide test system (Class II) |
| FDA Guidance Documents: | "Class II Special Control Guidance Document for B-Type Natriuretic
Peptide Premarket Notifications; Final Guidance for Industry and
FDA Reviewers" - 11/30/2000 |
| Predicate Device(s): | Roche Diagnostics Elecsys® proBNP immunoassay
(K022516/K032646) |
Device Description(s):
Method
The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The PBNP method is a one step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with polyclonal antibodies which recognize epitopes located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)] labeled polyclonal antibody specific for a second independent epitope on NT-proBNP, to form a particle/NT-proBNP/conjugate sandwich. Unbound conjugate is removed by magnetic separation and washing. After separation and washing, the particle/NT-proBNP/conjugate sandwich is transferred to the cuvette where the sandwich-bound ALP triggers an amplification cascade * ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to produce FAD. FAD binds to apo D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase produces multiple molecules of hydrogen peroxide (H2O2). H2O2 in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510 nm. The color change measured is directly proportional to the concentration of proBNP present in the patient sample.
*Technology licensed from London Biotechnology, Ltd., London, U.K.
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Intended Use:
Method
The Dimension® PBNP Flex® method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity of individuals suspected of having congestive heart failure and for risk stratification of patients with acute coronary syndrome and heart failure.
Comparison to Predicate Device:
Method
A summary of the features of the Dade Behring Dimension® PBNP Flex® method and the predicate Roche Diagnostics Elecsys® proBNP immunoassay is provided in the following chart. The Dade Behring Dimension® PBNP Flex® method utilizes the Roche polyclonal (sheep) antibody/antigen set.
| Feature | Dimension® PBNP
(K041417) | Roche Elecsys® proBNP
(K032646/K022516) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro quantitative
determination of N-terminal
pro-brain natriuretic peptide in
human plasma as an aid in the
diagnosis and assessment of
severity of individuals suspected of
having congestive heart failure.
The test is further indicated for the
risk stratification of patients with
acute coronary syndrome and heart
failure. | For the in vitro quantitative
determination of N-terminal
pro-
brain natriuretic peptide in human
serum and plasma as an aid in the
diagnosis of individuals suspected of
having congestive heart failure.
The test is further indicated for the
risk stratification of patients with
acute coronary syndrome and
congestive heart failure. |
| Assay Type
(detection) | immunoassay
(photometric) | immunoassay
(electrochemiluminescent) |
| Reportable Range | 5 - 30,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Roche Diagnostics'
polyclonal (sheep) antibody | polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL for patients less than 75
years and 450 pg/mL for patients 75
years and older | 125 pg/mL for patients less than 75
years and 450 pg/mL for patients 75
years and older |
| Feature | Dimension® PBNP
(K041417) | Roche Elecsys® proBNP
(K032646/K022516) |
| Analytical
Sensitivity | ≤ 10 pg/mL | 5 pg/mL |
| Functional
Sensitivity | ≤ 30 pg/mL | George M. Plummer Regulatory Affairs and Compliance Manager August 27, 2004
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
NOV 1 9 2004
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. George Plummer Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714
Re: K042347
Trade/Device Name: Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: November 2, 2004 Received: November 3, 2004
Dear Mr. Plummer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Division of Small Manufacturers, 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks. MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
510(k) Number (if known): K042347
Device Name:
Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method
Indications for Use:
The Dimension® PBNP Flex® method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure and for risk stratification and severity assessment of patients with acute coronary syndrome and heart failure.
| 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 Device Evaluation (ODE)
Carol Beman
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K042347
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