(74 days)
Not Found
No
The device description details a standard immunoassay based on chemiluminescent technology. There is no mention of AI, ML, or any computational algorithms beyond standard signal processing for quantitative measurement.
No.
The device is an in vitro diagnostic assay used to measure NT-proBNP levels, which aid in the diagnosis and assessment of severity for congestive heart failure. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The PBNP method is an in vitro diagnostic assay" and that measurements are "used as an aid in the diagnosis and assessment of severity" for congestive heart failure.
No
The device description clearly outlines physical components (reagents, beads, antibodies, calibrator vials) and a chemical reaction process, indicating it is an in vitro diagnostic assay with hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "The PBNP method is an in vitro diagnostic assay..." and "The PBNP CAL is an in vitro diagnostic product...". It also describes the use of the test to measure NT-proBNP in human serum and plasma to aid in the diagnosis and assessment of severity of congestive heart failure, and for risk stratification in patients with acute coronary syndrome and heart failure. These are all typical applications of in vitro diagnostics.
- Device Description: The description details a laboratory-based assay (chemiluminescent immunoassay) that analyzes biological samples (serum and plasma) outside of the body. This is the core characteristic of an in vitro diagnostic device.
- Predicate Device(s): The listed predicate devices are also described as "Flex® reagent cartridge" and "Calibrator," which are components of in vitro diagnostic systems.
The information provided clearly indicates that this device is intended to be used in a laboratory setting to analyze biological samples for diagnostic purposes, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
The PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.
Product codes
NBC, JIT
Device Description
Method: The PBNP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and a biotinylated monoclonal 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/NT-proBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to the biotin 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 Nterminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
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 less than 75 years old and patients 75 years and older.
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)
Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring Range: 5 - 35,000 pg/mL
Cut-off: 125 pg/mL for patients less than 75 years old and 450 pg/mL for patients 75 years and older.
Analytical Sensitivity: ≤ 5 pg/mL
Functional Sensitivity: ≤ 30 pg/mL
Analytical Specificity: Natrecor® shows no significant cross reactivity, 0 or 125 pg/mL NT-PBNP; sixteen other substances show no significant cross reactivity.
Interferences: No significant interference from: Bilirubin conjugated up to 60 mg/dL; Bilirubin unconjugated up to 60 mg/dL; Hemoglobin up to 1000 mg/dL; Triglyceride up to 3000 mg/dL
Hook Effect: No effect up to 400,000 pg/mL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of Safety and Effectiveness for the Dimension Vista® P-BNP Mono Flex® Reagent Cartridge (K6423A) and Dimension Vista® P-BNP Mono Calibrator (KC676A)
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.
A. 510(k) Number: K080578
MAY 1 6 2008
B. Date of Preparation: February 27, 2008
C. Proprietary and Established Names:
Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge (K6423A)
Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Calibrator (KC676A)
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Requlatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299
E. Regulatory Information:
Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge (K6423A)
-
- Regulation section: 21 CFR § 862.1117 B-type natriuretic peptide test system
-
- Classification: Class II
-
- Product Code: NBC, Test, Natriuretic Peptide
-
- Panel: Clinical Chemistry
Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Calibrator (KC676A)
-
- Requlation section: 21 CFR § 862.1150 Calibrator, Secondary
-
- Classification: Class II
-
- Product Code: JIT, Calibrator, Secondary
-
- Panel: Clinical Chemistry
F. Predicate Device:
The Dimension Vista® PBNP Flex® reagent cartridge (K6423A) and the Dimension Vista® PBNP Calibrator (KC676A) are substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423) and the Dimension Vista® PBNP Calibrator (KC676) both cleared under K061795.
G. Device Description:
Method
The PBNP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and a biotinylated monoclonal 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
1
with Chemibeads and biotinylated antibody to form a particle/NT-proBNP/biotiny|ated antibody sandwich. Sensibeads then are added and bind to the biotin 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 Nterminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
H. Intended 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 PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.
I. Substantial Equivalence Information:
The Dimension Vista® PBNP Flex® reagent cartridge (K6423A) and the Dimension Vista® PBNP Calibrator (KC676A) and the predicate devices, the Dimension Vista® PBNP Flex® reagent cartridge (K6423) and the Dimension Vista® PBNP Calibrator (KC676) were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:
Method
| Feature | Dimension Vista® PBNP Flex®
reagent cartridge (K6423A) | Dimension Vista® PBNP Flex®
reagent cartridge (K6423) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | 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 | 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 |
2
| coronary syndrome and heart failure. | coronary syndrome and heart failure. | |
|---|---|---|
| Device | ||
| Technology | ||
| (detection) | Chemiluminescent | Chemiluminescent |
| Measuring | ||
| Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Monoclonal Sheep Antibody | Polyclonal Sheep Antibody |
| Cut-off | 125 pg/mL for patients less than 75 | |
| years old and 450 pg/mL for patients | ||
| 75 years and older. | 125 pg/mL for patients less than 75 | |
| years old and 450 pg/mL for patients | ||
| 75 years and older. | ||
| Analytical | ||
| Sensitivity | ≤ 5 pg/mL | ≤ 5 pg/mL |
| Functional | ||
| Sensitivity | ≤ 30 pg/mL | ≤ 30 pg/mL |
| Analytical | ||
| Specificity | Natrecor® shows no significant cross | |
| reactivity, 0 or 125 pg/mL NT-PBNP; | ||
| sixteen other substances show no | ||
| significant cross reactivity. | Natrecor® shows no significant cross | |
| reactivity, 0 or 125 pg/mL NT-PBNP; | ||
| sixteen other substances show no | ||
| significant cross reactivity. | ||
| Interferences | No significant interference from: | |
| Bilirubin conjugated up to 60 mg/dL; | ||
| Bilirubin unconjugated up to 60 mg/dL; | ||
| Hemoglobin up to 1000 mg/dL; | ||
| Triglyceride up to 3000 mg/dL | No significant interference from: | |
| Bilirubin conjugated up to 60 mg/dL; | ||
| Bilirubin unconjugated up to 60 mg/dL; | ||
| Hemoglobin up to 680 mg/dL; | ||
| Triglyceride up to 3000 mg/dL | ||
| Hook Effect | No effect up to 400,000 pg/mL | No effect up to 400,000 pg/mL |
| Calibration | ||
| Interval | 30 days, same reagent lot | 30 days, same reagent lot |
| Sample | ||
| Volume | 8 µL | 8 µL |
Calibrator
| Feature | Dimension Vista® PBNP Flex®
Calibrator (KC676A) | Dimension Vista® PBNP Flex®
Calibrator (KC676) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | For the calibration of the N-Terminal
Pro-Brain Natriuretic Peptide (PBNP)
method for the Dimension Vista®
System. | For the calibration of the N-Terminal
Pro-Brain Natriuretic Peptide (PBNP)
method for the Dimension Vista®
System. |
| Analyte | Synthetic PBNP | Synthetic PBNP |
| Matrix | Bovine Albumin | Bovine Albumin |
| Form | Liquid, frozen | Liquid, frozen |
| Volume | Ten vials, two vials per level (A, B, C,
D, and E), 1.0 mL per vial. | Twelve vials, two vials per level (A, B,
C, D, E, and F), 1.0 mL per vial. |
| Levels | Five Levels, (0, 250, 1500, 12,000,
36.750 pg/mL) | Six levels, (0,125, 450, 1500, 12,000
and 36,750 pg/mL) |
J. Conclusion:
The Dimension Vista® PBNP Flex® reagent cartridge (K6423A) and the Dimension Vista® PBNP Calibrator (KC676A) are substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423) and the Dimension Vista® PBNP Calibrator (KC676) both cleared under K061795. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread and head facing to the left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Mr. Victory M. Carrio RA/QS Compliance Manager P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101
MAY 1 6 2008
Re: K080578
Trade/Device Name: Dimension Vista® N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-Type Natriuretic Peptide Regulatory Class: Class II Product Code: NBC, JIT Dated: February 29, 2008 Received: March 03, 2008
Dear Mr. Carrio:
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.
Yean 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
5
Indications For Use Statement
510(k) Number (if known):
KD80578
Device Name:
Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge (K6423A)
Indications for Use:
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 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.
Prescription Use X (Per 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 Benson
Sign-Off
ce of In Vitro Diagnostic Device Juation and Safety
Image /page/5/Picture/14 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'KQ80578'. The characters are written in a simple, slightly uneven style, suggesting they were written quickly or without strict adherence to a specific font. The overall impression is that of a handwritten code or identifier.
Page 172
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Indications For Use Statement
510(k) Number (if known): K
: K080578
Device Name:
Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Calibrator (KC676A)
Indications for Use:
The PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.
Prescription Use X (Per 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 Benam
... In Sign-Off
ിന്ce of In Vitro Diagnostic Device "ration and Safety
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