(45 days)
Not Found
No
The device description details a standard immunoassay technology and data analysis is performed by a microprocessor, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for quantitative determination and aid in the diagnosis and assessment of severity, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma" and that "measurements of NTproBNP 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 physical assay kit (TestPak) and its interaction with a hardware analyzer (Stratus® CS Stat Fluorometric Analyzer) to perform the test and measure the results. While the analyzer contains a microprocessor for data analysis, the core of the medical device is the in vitro diagnostic assay and the hardware required to run it, 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 Stratus® CS Acute Care™ NT-proBNP method is an "in vitro diagnostic assay".
- Purpose: The assay is designed to quantitatively determine NT-proBNP in human plasma, which is a biological sample taken from the body.
- Diagnostic Aid: The results are used as an "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. This clearly indicates a diagnostic purpose.
- In Vitro: The description of the assay process (two-site sandwich assay, solid phase Radial Partition Immunoassav (RPIA) technology, reactions on glass fiber paper) confirms that the testing is performed outside of the living body, which is the definition of "in vitro".
N/A
Intended Use / Indications for Use
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparanized 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 Stratus® CS Acute Care™ NT-proBNP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassav (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the pBNP TestPak. This antibody recognizes a distinct antigenic site on the NT-proBNP molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of NT-proBNP in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence: All data analysis functions are performed by the microprocessor within the analyzer.
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
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Intended User / Care Setting
trained health care professionals on the Stratus® CS Stat Fluorometric Analyzer in the clinical laboratory and point of care (POC) settings.
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)
Method Comparison: A split sample method comparison demonstrated good agreement between the revised Dade Behring Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak method and the current (predicate) Dade Behring pBNP TestPak method with heparinized plasma patient samples. Slope: 1.02, Intercept: 8.2 pg/mL, Correlation Coefficient: 0.99, n: 148. The range of NT-proBNP values for the monoclonal method in the correlation study was: 15.8 - 18914.2 pg/mL.
Lithium Heparin versus Sodium Heparin: Comparison of lithium heparin versus sodium heparin samples on the Stratus® CS system showed very good agreement. Fifty-one samples were tested in duplicate. The lithium heparin values ranged from 31.2 to 16, 445 pg/mL and sodium heparin values from 32.2 to 17,769 pg/mL. A linear regression gave a slope of 1.06, an intercept of -75 pg/mL and a correlation coefficient of 0.997.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: ≤15 pg/mL
Functional Sensitivity: ≤ 50 pg/mL
Analytical Specificity: The pharmaceutical Natrecor® shows no significant cross reactivity at 0 and 125 pg/mL NT-proBNP; sixteen other substances also show no significant cross reactivity.
Interferences: No significant interference from: bilirubin, conj. up to 60 mg/dL, bilirubin, unconjugated up to 60 mg/dL, hemoglobin up to 1000 mg/dL, lipemia up to 3000 mg/dL, rheumatoid factors up to 500 IU/mL
Hook Effect: No high dose effect (up to 833,585 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.
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
AUG 1 7 2007
510(k) Summary
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: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | June 30, 2007 |
| Name of Product(s): | Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak |
| FDA Classification Name(s): | B-type natriuretic peptide test system |
| 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):
TestPak | Dade Behring Stratus® CS Acute Care™ NT-proBNP (pBNP)
(K043476/K060548) |
Device Description(s):
Method
The Stratus® CS Acute Care™ NT-proBNP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassav (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the pBNP TestPak. This antibody recognizes a distinct antigenic site on the NT-proBNP molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of NT-proBNP in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence: All data analysis functions are performed by the microprocessor within the analyzer.
Intended Use:
Method
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparanized plasma. In individuals suspected of having congestive heart failure (CHF),
1
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.
Comparison to Predicate Device:
A summary of the features of the revised Dade Behring Stratus® CS Acute Care™ pBNP TestPak and the current (predicate) Dade Behring Stratus® CS Acute Care™ pBNP immunoassay (K043476/K060548) is provided in the following charts.
| Feature | Revised Stratus® CS Acute
Care™ pBNP | Current Stratus® CS pBNP |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro quantitative
determination of N-terminal pro-
brain natriuretic peptide in human
plasma as an aid in the diagnosis
and assessment of severity of
individuals suspected of having
congestive heart failure. 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 plasma
as an aid in the diagnosis and
assessment of severity of individuals
suspected of having congestive heart
failure. The test is further indicated
for the risk stratification of patients
with acute coronary syndrome and
heart failure. |
| Assay Type
(detection) | fluorometric immunoassay | fluorometric immunoassay |
| Reportable Range | 15- 20,000 pg/mL | 15- 20,000 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 | ≤15 pg/mL | ≤15 pg/mL |
| Functional
Sensitivity | ≤ 50 pg/mL | ≤ 50 pg/mL |
2
| Analytical
Specificity | The pharmaceutical Natrecor®
shows no significant cross reactivity
at 0 and 125 pg/mL NT-proBNP;
sixteen other substances also show
no significant cross reactivity | The pharmaceutical Natrecor® shows
no significant cross reactivity at 0 and
125 pg/mL NT-proBNP; sixteen other
substances also show no significant
cross reactivity |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences | No significant interference from:
bilirubin, conj. up to 60 mg/dL
bilirubin, unconjugated up to 60
mg/dL, hemoglobin up to 1000
mg/dL, lipemia up to 3000 mg/dL,
rheumatoid factors up to 500 IU/mL | No significant interference from:
bilirubin, conj. up to 60 mg/dL
bilirubin, unconjugated up to 60
mg/dL, hemoglobin up to 1000
mg/dL, triglycerides up to 3000
mg/dL, rheumatoid factors up to 750
IU/mL |
| Hook Effect | No high dose effect
( up to 833,585 pg/mL) | No high dose effect
( up to 1,400,000 pg/mL) |
| Calibration Interval | Calibration curve updated for each
lot, using one level and every 30
days, thereafter with the same
reagent lot. After calibration update
at completion of each test,
recovered values are calculated
from stored calibration coefficients. | Calibration curve updated for each
lot, using one level and every 30
days, thereafter with the same reagent
lot. After calibration update at
completion of each test, recovered
values are calculated from stored
calibration coefficients. |
| Sample Volume | 50 uL | 50 uL |
Method performance Summary:
Analytical Results
Method Comparison
A split sample method comparison demonstrated good agreement between the revised Dade Behring Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak method and the current (predicate) Dade Behring pBNP TestPak method with heparinized plasma patient samples.
| Comparative | Intercept | Correlation | ||
|---|---|---|---|---|
| Method | Slope | (pg/mL) | Coefficient | n |
| Dade Behring pBNP | 1.02 | 8.2 | 0.99 | 148 |
The model equation for Passing-Bablok linear regression statistics is: [results for revised Stratus CS pBNP] = slope x [comparative method results] + intercept. The range of NT-proBNP values for the monoclonal method in the correlation study was: 15.8 - 18914.2 pg/mL.
Lithium Heparin versus Sodium Heparin
Comparison of lithium heparin versus sodium heparin samples on the Stratus® CS system showed very good agreement. Fifty-one samples were tested in duplicate. The lithium heparin values ranged from
3
31.2 to 16, 445 pg/mL and sodium heparin values from 32.2 to 17,769 pg/mL. A linear regression gave a slope of 1.06, an intercept of -75 pg /mL and a correlation coefficient of 0.997.
Comments on Substantial Equivalence:
Both the revised Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak and the current Dade Behring pBNP immunoassays are intended for the quantitative determination of NT-proBNP. Comparative data for human plasma samples demonstrate good analytical agreement between the methods.
Conclusion:
The revised Dade Behring ® CS Acute Care™ NT-proBNP (pBNP) TestPak and the current (predicate) Dade Behring pBNP immunoassays (K043476/K060548) are substantially equivalent based on their intended use and performance characteristics as described above.
George M. Plummer Regulatory Affairs and Compliance Manager June 30, 2007
4
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring Inc. c/o Mr. George M. Plummer Regulatory Affairs & Compliance Manager Bldg. 400, M.S. 514 P.O. Box 6101 Newark, DE 19714-6101
Re: K071834 Trade/Device Name: Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak Regulation Number: 21 CFR §862.1117 Regulation Name: B-type Natriuretic Peptide Test System. Regulatory Class: Class II Product Code: NBC
Dated: June 30, 2007 Received: July 03, 2007
Dear Mr. Plummer:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
AUG 17 2007
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 1egally 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
6
INDICATIONS FOR USE STATEMENT
510(k) Number (If Known): k 071834
Device(s) Name(s):
Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak
Indications for Use:
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) 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 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. This method is for use by trained health care professionals on the Stratus® CS Stat Fluorometric Analyzer in the clinical laboratory and point of care (POC) settings.
Prescription Use X (Part 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
Division Sign-Off
Office of In Vitro Diagnostic D Evaluation and Safe