(61 days)
Not Found
No
The device description details a standard immunoassay technology with data analysis performed by a microprocessor, without mentioning any AI or ML techniques.
No
This device is an in vitro diagnostic assay used for aiding in the diagnosis and assessment of severity of congestive heart failure by measuring NT-proBNP levels in human plasma. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Stratus® CS Acute Care™ NT-proBNP method is an "in vitro diagnostic assay" and its measurements are "used as an aid in the diagnosis" of congestive heart failure.
No
The device description clearly outlines a hardware-based in vitro diagnostic assay using Radial Partition Immunoassay (RPIA) technology and an optical system within an analyzer to measure reaction rates. While a microprocessor performs data analysis, the core functionality relies on physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic assay..."
- "The NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product..."
- "The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product..."
This clearly indicates that the device and its associated components are intended for use in vitro (outside of the living body) for diagnostic purposes.
N/A
Intended Use / 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 buman 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.
The NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the NT-proBNP method on the Stratus® CS analyzer.
The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product intended to be used for dilution of the NT-proBNP Method on the Stratus® CS analyzer.
Product codes (comma separated list FDA assigned to the subject device)
NBC; JIT
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 polyclonal 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 polvclonal 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.
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 five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent: The Dade Behring pBNP Diluent is a refrigerated product containing a buffered bovine protein matrix with stabilizers and preservative. The kit consists of 5 DilPaks with diluent in one well.
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
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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 healthy individuals and individuals with diabetes, hypertension, and pulmonary disease. For the Disease Study Group, blood samples were obtained from 234 patients diagnosed with congestive heart failure (CHF); this population included 70 women and 164 men.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Results:
The high level of equivalence between the two assays on clinical performance measures justifies using the same cutoffs for the Stratus® CS Acute Care™ pBNP assay as the Elecsys® proBNP predicate device, as shown below:
Patients =75 yrs):
Stratus® CS pBNP Sensitivity (%): 90% (84 – 95) / 92% (84 – 99)
Stratus® CS pBNP Specificity (%): 92% (86 – 98) / 73% (61 – 84)
Stratus® CS pBNP NPV: 86% (79 – 94) / 92% (84 – 100)
Female Patients (=75 yrs):
Stratus® CS pBNP Sensitivity (%): 84% (74-94) / 95% (85-100)
Stratus® CS pBNP Specificity (%): 92% (87-97) / 85% (76-94)
Stratus® CS pBNP NPV: 92% (87-97) / 98% (94-100)
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.
Roche Diagnostics Elecsys® proBNP immunoassay and CalSet calibrator (K032646/K022516)
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
FEB 1 5 2005
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: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | December 14, 2004 |
| Name of Product(s): | Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak assay
Stratus® CS pBNP CalPak (the assay calibrator)
Stratus® CS pBNP DilPak (the assay diluent) |
| FDA Classification Name(s): | B-type natriuretic peptide test system and calibrator (all 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 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 polyclonal 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 polvclonal 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
1
reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
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 five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Dade Behring pBNP Diluent is a refrigerated product containing a buffered bovine protein matrix with stabilizers and preservative. The kit consists of 5 DilPaks with diluent in one well.
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), 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 (CalPak), REF CPBNP-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ NT-proBNP method (pBNP).
Diluent
The NT-proBNP Dilution Pak (DilPak), REF CPBNP-D, is an in vitro diagnostic product intended to be used in conjunction with the pBNP TestPak, REF CPBNP, on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP.
Comparison to Predicate Device:
Method
A summary of the features of the Dade Behring Stratus® CS Acute Care™ pBNP TestPak and the predicate Roche Diagnostics Elecsys® proBNP immunoassay (K032646/K022516) is provided in the following charts. The Dade Behring pBNP TestPak utilizes the Roche polyclonal (sheep) antibody/antigen set.
2
Method:
:
·
| Feature | Stratus® CS Acute Care™ 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 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 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 | |
| (fluorometric) | immunoassay | |
| (electrochemiluminescent) | ||
| Reportable Range | 15- 20,000 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 | 15 pg/mL | 5 pg/mL |
| Functional | ||
| Sensitivity | George M. Plummer Regulatory Affairs and Compliance Manager December 14, 2004 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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 with three wave-like lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 5 2005
Mr. George M. Plummer Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community Building 500, MS 514 PO Box 6101 Newark, DE 19714
Re: K043476
K043470
Trade/Device Name: Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak assay Stratus® CS pBNP CalPak Stratus® CS pBNP DilPak Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT Dated: December 14, 2004 Received: December 16, 2004
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, do floos that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may attress, 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 n may of caojoer of the 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 r houre of action and 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 or any 1 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,
Sean M. Cooper MS, DUM
Jean 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
9
INDICATIONS FOR USE STATEMENT
Ko43476 510(k) Number (If Known):
Device(s) Name(s):
Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak assay Stratus® CS pBNP CalPak Stratus® CS pBNP DilPak
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 buman 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.
The NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the NT-proBNP method on the Stratus® CS analyzer.
The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product intended to be used for dilution of the NT-proBNP Method on the Stratus® CS analyzer.
✓
510(k) Numbe
Prescription Use (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)
(Division Sign-Off)
Division of Clinical Laboratory Devices