(11 days)
Not Found
No
The description details a standard immunoassay technology (LOCI®) for measuring a specific biomarker. There is no mention of AI, ML, or any computational analysis beyond the direct measurement of the chemiluminescent signal.
No
This device is an in vitro diagnostic assay used to measure NT-proBNP levels, aiding in the diagnosis and risk stratification of heart failure, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the NTP method is "an in vitro diagnostic assay" and that measurements are "used as an aid in the diagnosis and assessment of severity" for individuals suspected of having congestive heart failure.
No
The device description clearly outlines a chemiluminescent immunoassay based on LOCI® technology, involving physical reagents (beads, antibodies) and a chemical reaction triggered by light. This is a hardware-based in vitro diagnostic assay, not a software-only device.
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 NTP method is an in vitro diagnostic assay.
- Sample Type: It measures NT-proBNP in human serum and plasma, which are biological samples taken from the body.
- Purpose: The measurements are used as an 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 all diagnostic purposes performed outside of the living body.
- Device Description: The description details a laboratory-based immunoassay process using reagents to analyze the sample.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NTP 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® EXLTM integrated chemistry system with LOCI® Module. 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 EXL NTP 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.
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)
Comparative testing performed by Siemens Healthcare Diagnostics Inc. demonstrates substantial equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring Range: 5 - 35,000 pg/mL
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): 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.
K080578
Dimension Vista® PBNP Flex® reagent cartridge (K6423A) cleared under K080578.
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 2 2 2008
510(k) Summary of Safety and Effectiveness for the
Dimension® EXL™ NTP Flex® Reagent Cartridge (RF623)
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: K082645
B. Date of Preparation: August 15, 2008
C. Proprietary and Established Names:
Dimension® EXL™ N-terminal Pro-Brain Natriuretic Peptide (NTP) Flex® Reagent Cartridge (RF623)
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101
Victor M. Carrio, Senior Manager, Regulatory Affairs
Office: (302) 631-0376 Fax: (302) 631-6299
E. Regulatory Information:
-
- Regulation section: 21 CFR § 862.1117 B-type natriuretic peptide test system
-
- Classification: Class II
-
- Product Code: NBC, Test, Natriuretic Peptide
-
- Panel: Clinical Chemistry
F. Predicate Device:
The Dimension® EXLTM N-terminal Pro-Brain Natriuretic Peptide (NTP) Flex® Reagent Cartridge (RF623) is substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423A) cleared under K080578.
G. Device Description:
1
The EXL NTP 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 NTproBNP 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.
H. Intended Use:
The NTP 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® EXLTM integrated chemistry system with LOCI® Module. 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.
I. Substantial Equivalence Information:
The Dimension® EXL™ N-terminal Pro-Brain Natriuretic Peptide (NTP) Flex® Reagent Cartridge (RF623) and the Dimension Vista® PBNP Flex® reagent cartridge (K6423A), cleared under K080578, were compared. A comparison of the important similarities and differences between the device and the predicate is provided in the following table:
| Feature | Dimension® EXLT™ NTP Flex®
Reagent Cartridge (RF623) | Dimension Vista® PBNP Flex®
reagent cartridge (K6423A) |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K080578 |
| Intended
Use | The NTP method is an in vitro | The PBNP method is an in vitro |
| | diagnostic assay for the | diagnostic assay for the |
| | quantitative measurement of N- | quantitative measurement of N- |
| | terminal pro-brain natriuretic | terminal pro-brain natriuretic |
| | peptide (NT-proBNP) in human | peptide (NT-proBNP) in human |
| | serum and plasma on the | serum and plasma on the |
| | Dimension® EXLT™ integrated | Dimension Vista® System. In |
| | chemistry system with LOCI® | individuals suspected of having |
| | Module. In individuals suspected | congestive heart failure (CHF), |
| | of having congestive heart failure | measurements of NT-proBNP are |
| | (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. | 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. |
| Device
Technology
(detection) | Chemiluminescent | Chemiluminescent |
| Measuring
Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Monoclonal Sheep Antibody | Monoclonal 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
1000 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 |
2
J. Conclusion:
The Dimension® EXL™ N-terminal Pro-Brain Natriuretic Peptide (NTP) Flex® Reagent Cartridge (RF623) is substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423A) cleared under K080578. Comparative testing performed by Siemens Healthcare Diagnostics Inc. demonstrates substantial equivalent performance.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Victor Carrio Senior Manager of Regulatory Affairs P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101
Re: K082645
Trade Name: Dimension® EXL™ LOCI® N-terminal Pro-Brain Natriuretic Peptide (NTP) Flex® Reagent Cartridge (RF623) Regulation Number: 21 CFR 862.1117 Regulation Name: B-type Natriuretic Peptide Test System Regulatory Class: Class II Product Codes: NBC Dated: September 10, 2008 Received: September 11, 2008
SEP 2 2 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).
4
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 I o(x) marketed predicate device results in a classification for your device and thus, permites 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 Inc Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please onte 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 the from the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean m. Cooper, M.S., D.V.M.
Sean 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):
Device Name:
Dimension® EXL™ LOCI® N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge (RF623)
Indications for Use:
The NTP method is an in vitro diagnostic assay for the quantitative measurement of Nterminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension® EXLTM integrated chemistry system with LOCI® Module. 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 (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)
Division Sign-Off
f In Virc Diagnostic Device