(36 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.
This device is an in vitro diagnostic assay used for the quantitative determination of NT-proBNP, which aids in the diagnosis, assessment of severity, and risk stratification of patients with certain heart conditions. It does not directly treat or alleviate a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the PBNP assay is an "in vitro diagnostic assay" and is used as an "aid in the diagnosis and assessment of severity" for conditions like congestive heart failure.
No
The device description clearly outlines a complex in vitro diagnostic assay involving chemical reactions, magnetic separation, and enzymatic processes, which are hardware-dependent components and not solely software.
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 assay is an "in vitro diagnostic assay for the quantitative determination of Nterminal pro-brain natriuretic peptide (NT-proBNP) in human serum or plasma."
- Sample Type: The assay is performed on human serum or plasma, which are biological samples taken from the body.
- Purpose: The results are used to aid in the diagnosis and assessment of severity of congestive heart failure (CHF) and for risk stratification in patients with acute coronary syndrome and heart failure. These are clinical purposes related to patient health.
- Method: The "Device Description" details a laboratory-based immunoassay method performed outside of the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PBNP assay used on the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum or plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the 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 PBNP method is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with monoclonal antibodies, which recognize an epitope located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)} labeled monoclonal 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 (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). the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-H2O2 in a 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 NT-proBNP present in the patient sample.
Mentions image processing
Not Found
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.”
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
Ko71767
AUG 2 4 2007
Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation 1.
| Manufacturer: | Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714 |
|----------------------|------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714
Attn: Pamela A. Jurga
Tel: 302-631-8891 |
Date of Preparation:
June 28, 2007
2. Device Name / Classification
- . Dimension® PBNP reagent cartridge/ Class II
3. Identification of the Predicate Device
FDA Guidance Document(s):
- "Class II Special Control Guidance Document for B-Type Natriuretic . Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers" - 11/30/2000
- "Deciding When to Submit a 510(k) for a Change to an Existing Device"-. 1/10/1997
Device Description(s): 4.
The PBNP method is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with monoclonal antibodies, which recognize an epitope located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)} labeled monoclonal 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 (FADP) to produce FAD. FAD
1
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). the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-H2O2 in a 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 NTproBNP present in the patient sample.
*Technology licensed from London Biotechnology, Ltd., London, U.K.
5. Device Intended Use:
The PBNP assay used on the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum or plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
Medical device to which equivalence is claimed: 6.
Substantial Equivalence:
This product is substantially equivalent to other B-type natriuretic peptide test systems, such as the Dimension® PBNP Flex® reagent cartridge immunoassay (K041417/K042347).
Comparison to Predicate Device:
The modified Dade Behring Dimension® PBNP method and the current Dade Behring Dimension® PBNP method are both in vitro diagnostic immunoassays intended for the quantitative measurement of Nterminal pro-brain natriuretic peptide. A summary of the two methods is included in the following table.
| Feature | Dimension® PBNP-mono | Dimension® PBNP
(K041417/K042347) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PBNP assay used on the
Dimension® clinical chemistry
system with the heterogeneous
immunoassay module is an in vitro
diagnostic assay for the quantitative
determination of N-terminal pro-
brain natriuretic peptide (NT-
proBNP) in human serum or
plasma. In individuals suspected of
having congestive heart failure
(CHF), measurements of NT-
proBNP are used as an aid in the
diagnosis and assessment of
severity. The test is further
indicated for the risk stratification | The PBNP assay used on the
Dimension® clinical chemistry
system with the heterogeneous
immunoassay module is an in vitro
diagnostic assay for the quantitative
determination of N-terminal pro-brain
natriuretic peptide (NT-proBNP) in
human plasma. In individuals
suspected of having congestive heart
failure (CHF), measurements of NT-
proBNP are used as an aid in the
diagnosis and assessment of severity.
The test is further indicated for the
risk stratification of patients with
acute coronary syndrome and heart |
| | of patients with acute coronary
syndrome and heart failure. | |
| Assay Type
(detection) | immunoassay
(chemiluminescent) | immunoassay
(chemiluminescent) |
| Reportable Range | 10 - 30,000 pg/mL | 10 - 30,000 pg/mL |
| Antibody | monoclonal (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 |
| Analytical
Sensitivity | ≤ 10 pg/mL | ≤ 10 pg/mL |
| Functional
Sensitivity | ≤ 30 pg/mL | ≤ 30 pg/mL |
| Analytical
Specificity | Natrecor® shows no significant
cross reactivity, 0 or 125 pg/mL
NT-proBNP; sixteen other
substances show no significant
cross reactivity | Natrecor® shows no significant cross
reactivity, 0 or 125 pg/mL NT-
proBNP; sixteen other substances
show no significant cross reactivity |
| Interferences | No significant interference from:
Bilirubin, conj. up to 60 mg/dL
bilirubin, unconj. up to 60 mg/dL
hemoglobin up to 1000 mg/dL
triglycerides up to 3000 mg/dL
rheumatoid factors up to 500 IU/mL | No significant interference from:
Bilirubin, conj. up to 60 mg/dL
bilirubin, unconj. up to 20 mg/dL
hemoglobin up to 1000 mg/dL
triglycerides up to 3000 mg/dL
rheumatoid factors up to 500 IU/mL |
| Hook Effect | No effect up to 300,000 pg/mL | No effect up to 300,000 pg/mL |
| Calibration Interval | 30 days - same reagent lot | 30 days - same reagent lot |
| Sample Volume | 50 uL | 50 uL |
2
:
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:
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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Comments on Substantial Equivalence:
Both the modified Dade Behring Dimension® PBNP and the current Dade Behring Dimension® PBNP immunoassays are intended for the quantitative determination of NT-proBNP. Comparative data for human samples demonstrate good analytical and clinical agreement between the methods.
Conclusion:
The modified Dade Behring Dimension® PBNP method and the predicate Dade Behring Dimension® PBNP method (K041417/K042347) are substantially equivalent based on their intended use and performance characteristics as described above.
Pamela A. Jurga
Pamela A. Jurga Regulatory Affairs and Compliance Manager June 28, 2007
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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 stylized eagle with three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. c/o Ms. Pamela A. Jurga Regulatory Affairs & Compliance Manager Glasgow Business Community Bldg. 500 M.S. 514 P.O. Box 6101 Newark, DE 19714
AUG 2 4 2007
Re: K071767
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: June 28, 2007 Received: June 29, 2007
Dear Ms. Jurga:
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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Page 2 -
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
6
Indications for Use
510(k) Number (if known):
Device Name:
Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method
Indications For Use:
The PBNP assay used on the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic assay for the quantitative determination of Nterminal pro-brain natriuretic peptide (NT-proBNP) in human serum or plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
Ko7/767