(132 days)
No
The description details a standard immunoassay and fluorometric analysis process. There is no mention of AI or ML algorithms being used for data analysis or interpretation, only that the analysis is performed automatically by the analyzer.
No
Explanation: The device is described as an "in vitro diagnostic test" for measuring D-dimer in plasma, which is used for diagnostic purposes and does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Dade Behring Stratus® CS D-dimer method is an in vitro diagnostic test."
No
The device description clearly outlines a physical cartridge (TestPak) containing reagents and glass fiber paper, designed for use with a specific hardware analyzer (Stratus® CS fluorometric analyzer). While the analyzer performs data analysis functions automatically, the core of the device is a physical in vitro diagnostic test kit, not software alone.
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 device is an "in vitro diagnostic test".
- Method: The device performs a test on a biological sample (plasma) outside of the body ("in vitro").
- Purpose: The test is used to determine the concentration of a specific substance (D-dimer) in the sample, which is a diagnostic measurement.
N/A
Intended Use / Indications for Use
The Dade Behring Stratus® CS D-dimer method is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma.
The Dade Behring Stratus® CS D-dimer method is an in vitro diagnostic test intended for use with the Stratus® CS fluorometric analyzer for the determination of cross-linked fibrin degradation products (D-dimer) in plasma.
Product codes
DAP
Device Description
The Dade Behring Stratus® CS D-dimer TestPak method is an enzyme-linked fluorescent immunoassay that consists of a five(5)- well, plastic cartridge (TestPak) designed for use only on the Dade Behring Stratus® CS fluorometric analyzer. Within the TestPak cartridge is a small square of embedded glass fiber paper. Reagents and sample are added through an opening onto the glass fiber paper. Following incubation, the enzyme-labeled antibody and the bound D-dimer fraction react. The enzymatic rate of the bound fraction increases with the concentration of the D-dimer in the sample and is measured via fluorescence. Dilutions, if needed, may be accomplished via utilization of the Stratus®CS DilPak (diluent) cartridges. All data analysis functions are performed automatically by 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
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)
Split sample comparison with citrated human plasma samples between the Stratus® D-dimer method and the VIDAS® D-dimer (DD) assay gave a correlation coefficient of 0.923, a slope of 0.995 and an intercept of 159 ng/mL. In this study, clinical patient samples (n = 123) were tested at Dade Behring (Glasgow, Delaware) and ranged from 79 ng/mL to 5689 ng/mL as tested on the VIDAS® D-dimer assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
0
1022976
JAN 1 6 2003
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: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | September 4, 2002 |
| Name of Product: | Dade Behring Stratus® CS D-dimer method; includes separately
supplied TestPak (assay) and DilPak (diluent) |
| FDA Classification Name: | Fibrinogen/fibrin degradation products assay |
| Predicate Device: | bioMerieux Vitek VIDAS® D-dimer Assay (K973819) |
| Device Description: | The Dade Behring Stratus® CS D-dimer TestPak method is an enzyme-linked fluorescent immunoassay that consists of a five(5)- well, plastic cartridge (TestPak) designed for use only on the Dade Behring Stratus® CS fluorometric analyzer. Within the TestPak cartridge is a small square of embedded glass fiber paper. Reagents and sample are added through an opening onto the glass fiber paper. Following incubation, the enzyme-labeled antibody and the bound D-dimer fraction react. The enzymatic rate of the bound fraction increases with the concentration of the D-dimer in the sample and is measured via fluorescence. Dilutions, if needed, may be accomplished via utilization of the Stratus®CS DilPak |
1
(diluent) cartridges. All data analysis functions are performed automatically by the analyzer. The Dade Behring Stratus® CS D-dimer method is an in vitro Intended Use: diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus® CS D-dimer method is substantially equivalent Comparison to Predicate Device: in technological design and intended use to other D-dimer assays such as the bioMerieux Vitek VIDAS® D-dimer assay (K973819). A comparison of the features of these products is provided below:
| Feature | Dade Behring Stratus® CS
D-dimer Method | bioMerieux Vitek VIDAS®
D-dimer Assay |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | in vitro use | in vitro use |
| Technology: | Automated
Fluorescent immunoassay; 450nm
Alkaline phosphatase = conjugate
4-methylumbelliferyl phosphate = substrate | Automated
Fluorescent immunoassay; 450 nm
Alkaline phosphatase = conjugate
4-methylumbelliferyl phosphate = substrate |
| Sample: | whole blood/plasma | plasma |
| Sample volume: | 75 uL | 200 uL |
| Assay range: | 6 - 5000 ng/mL | 45 - 1000 ng/mL |
| Calibration: | Calibration curve updated for each lot,
using one level (triplicate) and every
60 days, thereafter. After calibration
update at completion of each test, recovered
values are calculated from stored calibration
coefficients. | One point calibrator tested (duplicate) with each
lot initially and every 14 days, thereafter. |
Comments on Substantial Equivalence:
Split sample comparison with citrated human plasma samples between the Stratus® D-dimer method and the VIDAS® D-dimer (DD) assay gave a correlation coefficient of 0.923, a slope of 0.995 and an intercept of 159 ng/mL. In this study, clinical patient
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samples (n = 123) were tested at Dade Behring (Glasgow, Delaware) and ranged from 79 ng/mL to 5689 ng/mL as tested on the VIDAS® D-dimer assay.
Conclusion:
The Dade Behring Stratus® CS D-dimer (DDMR) method and the bioMerieux Vitek VIDAS® Ddimer (DD) assay are substantially equivalent in intended use, technological design and specific performance characteristics, including split sample comparison results as noted above.
KimVaught
Richard M. Vaught Regulatory Affairs and Compliance Manager September 4, 2002
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site, Bldg. 500, Box 514 P.O. Box 6101 Newark, Delaware 19714-6101
JAN 1 6 2003
K022976 Re:
Trade/Device Name: Stratus® CS D-dimer (DDMR) Method Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrin Degradation Products Regulatory Class: II Product Code: DAP Dated: December 18, 2002 Received: December 20, 2002
Dear Mr. Vaught:
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). 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.
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely vours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Device Name:
Stratus® CS D-dimer (DDMR) Method
Indications for Use:
The Dade Behring Stratus® CS D-dimer method is an in vitro diagnostic test intended for use with the Stratus® CS fluorometric analyzer for the determination of cross-linked fibrin degradation products (D-dimer) in plasma.
Rmplinight
chard M. Vaught Regulatory Affairs and Compliance Manager
September 4, 2002
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jacchini Bautista
(Division Sin-Off)
Division of clinical Laboratory Devices
510(k) Number K022976
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)