(54 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and optical measurement. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for calculating concentrations.
No
Explanation: This device is an in vitro diagnostic assay used for the quantitative determination of NT-proBNP in human plasma, which aids in the diagnosis of congestive heart failure. It does not provide treatment or directly manage a patient's health condition, but rather provides information for diagnostic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic assay" and that "Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure."
No
The device is an in vitro diagnostic assay that utilizes chemical reagents and a clinical chemistry system (hardware) to perform the test. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Dade Behring Dimension® PBNP Flex® reagent cartridge method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma."
The "Device Description" also describes it as an "in vitro diagnostic test".
These statements clearly indicate that the device is intended for use in examining specimens derived from the human body to provide information for the diagnosis of disease, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dade Behring Dimension® PBNP Flex® reagent cartridge 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.
The Dade Behring Dimension® PBNP Calibrator is intended to be used to calibrate the N-terminal pro-brain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system.
Product codes
NBC, JIT
Device Description
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 an epitope 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/coniugate 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.
Calibrator
The Dade Behring PBNP Calibrator is a frozen liquid product containing synthetic human NT-proBNP in a bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials at each of five levels, 1.0 mL in each vial.
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
Patients =75 years.
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
For the Reference Study Group, NT-proBNP concentrations were determined in 308 individuals without congestive heart failure (163 women and 145 men); this population included apparently health individuals and individuals with diabetes, hypertension, and pulmonary disease. For the Disease Study Group, blood samples were obtained from 227 patients diagnosed with congestive heart failure (CHF); this population included 69 women and 158 men.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL
For the Reference Study Group, NT-proBNP concentrations were determined in 308 individuals without congestive heart failure (163 women and 145 men); this population included apparently health individuals and individuals with diabetes, hypertension, and pulmonary disease. For the Disease Study Group, blood samples were obtained from 227 patients diagnosed with congestive heart failure (CHF); this population included 69 women and 158 men.
The clinical performance of the Dade Behring assay was substantially equivalent to that of the predicate device. Data used to calculate the values are from the method comparison and reference interval data sets generated at the University of Maryland Medical Center.
ANALYTICAL
Comparison using split patient heparinized plasma samples between the Dade Behring Dimension® PBNP Flex® method and the predicate Roche Elecsys® proBNP immunoassay demonstrated good agreement between the methods. The range of NT-proBNP values in the correlation study was: 16.1 to 29,893.1 pg/mL.
In addition, comparison of lithium heparin versus sodium heparin and EDTA plasma samples on the Dimension® system showed very good agreement. Lithium heparin samples ranging from 13 to 29,221 pg/mL when compared to sodium heparin and EDTA samples gave slopes of 0.95 and 0.96, correlation coefficients of 0.998 and 0.998, and intercepts of 0.9 and 10.9 respectively, using Passing-Bablok regression statistics.
Reproducibility:
Typical precision observed for the Dimension® PBNP Flex® method is summarized in a table with Mean, Within-Run Precision (SD and %CV), and Total Precision (SD and %CV) for Human Plasma Pool (Pool 1: 159.0 pg/mL) and Internal QC Pools (Pool 1: 449.5 pg/mL, Pool 2: 956.7 pg/mL), and AuditTM MicroFDTM BNP Control (Level 1: 175.5 pg/mL, Level 2: 3733.8 pg/mL).
The reproducibility testing was done in accordance with the NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A, 1999. Specimens at each level were analyzed in duplicate once per day for 20 days. The within-run and total standard deviations were calculated by the analysis of variance method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance of Dade Behring NT-proBNP assay vs. predicate device on Male patients.
=75 yrs (95% CI)
Sensitivity (%): Dimension® PBNP 91 (84 - 99), Elecsys® proBNP 91 (84 - 99)
Specificity (%): Dimension® PBNP 77 (67-88), Elecsys® proBNP 73 (61 - 84)
NPV: Dimension® PBNP 92, Elecsys® proBNP 92
Clinical Performance of Dade Behring NT-proBNP assay vs. predicate device on Female patients.
=75 yrs (95% CI)
Sensitivity (%): Dimension® PBNP 91 (79 – 100), Elecsys® proBNP 95 (87 – 104)
Specificity (%): Dimension® PBNP 88 (80–96), Elecsys® proBNP 87 (78–95)
NPV: Dimension® PBNP 96, Elecsys® proBNP 98
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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JUL 2 0 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: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | May 26, 2004 |
| Name of Product(s): | Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method,
and Dimension® PBNP Calibrator |
| FDA Classification Name(s): | B-type natriuretic peptide test system and calibrator (both 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 and CalSet
calibrator (K032646/K022516) |
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 an epitope 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/coniugate 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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Calibrator
Cantorator
The Dade Behring PBNP Calibrator is a frozen liquid product containing synthetic human NT-proBNP in a bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials at each of five levels, 1.0 mL in each vial.
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 of individuals suspected of having congestive heart failure (CHF).
Calibrator
The PBNP Calibrator is an in vitro diagnostic product intended to be used to calibrate the N-terminal probrain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system with the heterogeneous immunoassay module.
Comparison to Predicate Device:
A summary of the features of the Dade Behring Dimension® PBNP Flex® method and the predicate Roche Diagnostics Elecsys® proBNP immunoassay (K032646/K022516) is provided in the following chart. The Dade Behring Dimension® PBNP assay utilizes the same antibody/antigen set as the predicate, Roche Diagnostics Elecsys® proBNP immunoassay.
| Feature | Dimension® PBNP | Roche Elecsys® proBNP |
|---|---|---|
| Intended Use | For the in vitro quantitative | |
| determination of N-terminal | ||
| pro-brain natriuretic peptide in | ||
| human plasma as an aid in the | ||
| diagnosis of individuals suspected | ||
| of having congestive 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 | 10 - 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 Richard M. Vaught Regulatory Affairs and Compliance Manager May 26, 2004 |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
JUL 2 0 2004
Re: K041417
Trade/Device Name: Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method Dimension® PBNP Calibrator Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC, JIT Dated: May 26, 2004 Received: May 27, 2004
Dear Mr. Vaught:
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 (OS) 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 (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,
Jean M. Cooper, MS, DVM.
Tean 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
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INDICATIONS FOR USE STATEMENT
Device(s) Name(s):
Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method, and Dimension® PBNP Calibrator
Indications for Use:
The Dade Behring Dimension® PBNP Flex® reagent cartridge 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.
The Dade Behring Dimension® PBNP Calibrator is intended to be used to calibrate the N-terminal pro-brain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system.
RmVaught
Richard M. Vaught
Richard M. Vaught Regulatory Affairs and Compliance Manager
May 26, 2004
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Aleat Catz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041117
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