(80 days)
Not Found
No
The device description details a standard immunoassay technology (LOCI™) for measuring NT-proBNP. There is no mention of AI, ML, or any computational algorithms beyond standard signal processing for quantitative measurement. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an in vitro diagnostic assay used to measure NT-proBNP levels, aiding in the diagnosis and assessment of congestive heart failure and risk stratification. It is for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. 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." and "The Dimension Vista™ NT-proBNP (PBNP) calibrator is an in vitro diagnostic product...".
No
The device description clearly details physical reagents (latex beads, antibodies, dyes) and a frozen liquid calibrator, indicating it is a hardware-based in vitro diagnostic assay, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The PBNP method is an in vitro diagnostic assay..." and the description of the calibrator also states it is an "in vitro diagnostic product".
- Nature of the Test: The test measures a substance (NT-proBNP) in human serum and plasma, which are biological samples taken from the body. This is a key characteristic of in vitro diagnostics.
- Purpose of the Test: The test is used "as an aid in the diagnosis and assessment of severity" of congestive heart failure and for "risk stratification of patients with acute coronary syndrome and heart failure." These are clinical purposes for which IVDs are used.
- Device Description: The description details a laboratory-based immunoassay method (LOCI™ technology) that analyzes the sample outside of the body.
All of these points strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Method
The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. 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.
Calibrator
The NT-proBNP (PBNP) Calibrator is an in vitro diagnostic product intended to be used for calibration of N-terminal pro-brain natriuretic peptide (PBNP) method for the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
NBC, JIT
Device Description
Method
The PBNP method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated polyclonal antibody fragment which recognize an epitope located in the N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NT-proBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NTproBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.
Calibrator
The PBNP Calibrator is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in a bovine albumin matrix with stabilizers and preservative. The kit consists of eight vials, two each of four levels (A, B, C, and D), 1.0 mL per vial for levels A, C, and D and 1.5 mL per vial for level B. Description of the manufacturing, value assignment and stability testing processes are provided in Section 21.
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
SEP 1 1 2006
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: K061795
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
| 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 23, 2006 |
2. Device Name / Classification
- Dimension Vista™ PBNP reagent cartridge/ Class II .
- Dimension Vista™ PBNP calibrator/ 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
4. Device Description(s):
Method
The PBNP method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated polyclonal antibody fragment which recognize an epitope located in the
1
N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NT-proBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NTproBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.
Calibrator
The PBNP Calibrator is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in a bovine albumin matrix with stabilizers and preservative. The kit consists of eight vials, two each of four levels (A, B, C, and D), 1.0 mL per vial for levels A, C, and D and 1.5 mL per vial for level B. Description of the manufacturing, value assignment and stability testing processes are provided in Section 21.
5. Device Intended Use:
Method
The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal probrain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. In individuals suspected of having congestive heart failure (CHF), measurements of NTproBNP 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.
Calibrator
The NT-proBNP (PBNP) Calibrator is an in vitro diagnostic product intended to be used for calibration of N-terminal pro-brain natriuretic peptide (PBNP) method for the Dimension Vista™ System.
6. Medical device to which equivalence is claimed:
Substantial Equivalence:
These products are substantially equivalent to other B-type natriuretic peptide test systems, such as the Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516).
See examples of the predicate device labeling in Section 12.1.
Comparison to Predicate Device:
Method
The proposed Dade Behring Dimension Vista™ PBNP method and the predicate Roche Diagnostics Elecsys® proBNP immunoassay are both in vitro diagnostic immunoassays intended for the quantitative measurement of N-terminal pro-brain natriuretic peptide in human serum and heparinized plasma. See Section 12.1 for a copy of the predicate labeling. The Dade Behring Dimension Vista™ PBNP Flex® method utilizes the Roche polyclonal (sheep) antibody/antigen set. A summary of the features of the two assays is included in the table below.
2
:
| Feature | Dimension Vista® PBNP | Roche Elecsys® proBNP
(K032646/K022516) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro quantitative
measurement of N-terminal pro-
brain natriuretic peptide in human
serum and plasma. In individuals
suspected of having congested 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. | For the in vitro quantitative
determination of N-terminal pro-brain
natriuretic peptide in human serum
and plasma. The Elecsys proBNP
assay is used 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
(chemiluminescent) | immunoassay
(electrochemiluminescent) |
| Reportable Range | 5 - 35,000 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 |
| Analytical
Sensitivity | ≤ 5 pg/mL | 5 pg/mL |
| Functional
Sensitivity | ≤ 30 pg/mL | Trade/Device Name: Dimension® Vista™ NT-proBNP (PBNP) Flex® reagent cartridge method Dimension® Vista™ NT-proBNP (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: August 14, 2006 Received: August 15, 2006
Dear Ms. Pamela 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) 276-0484. 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 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/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. 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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Dade Behring Inc. Dimension Vista™ NT-proBNP (PBNP) Method and Calibrator 510(k) Premarket Notification
Indications for Use
40617
510(k) Number (if known):
Device Name:
- Dimension® Vista™ NT-proBNP (PBNP) Flex® reagent cartridge method .
- Dimension® Vista™ NT-proBNP (PBNP) calibrator .
Indications For Use:
Method
The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. 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.
Calibrator
The Dimension Vista™ NT-proBNP (PBNP) calibrator is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (PBNP) method on the Dimension Vista™ System.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use - - -(21 CFR 801)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety