(62 days)
Not Found
No
The device description details a chemical assay and optical measurement system with data analysis performed by a microprocessor, but there is no mention of AI or ML algorithms being used for data interpretation or decision making.
No
This device is an in vitro diagnostic test for the quantitative measurement of D-dimer, used as an aid in the diagnosis of venous thromboembolism, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the method "is an in vitro diagnostic test" and "is intended for use as an aid in the diagnosis of venous thromboembolism (VTE)".
No
The device description clearly outlines a physical in vitro diagnostic test kit (DDMR TestPak) and a physical analyzer (Stratus® CS STAT fluorometric analyzer) that performs the assay and data analysis. This is 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 method is an "in vitro diagnostic test."
- Sample Type: It specifies that the test is performed on "human citrated or heparinized plasma," which is a biological sample taken from the body.
- Purpose: The test is intended for the "quantitative measurement of cross-linked fibrin degradation products (D-dimer)" and is used "as an aid in the diagnosis of venous thromboembolism (VTE)." This clearly indicates a diagnostic purpose performed outside of the body.
- Device Description: The description details a laboratory-based assay procedure involving chemical reactions and measurement of a substance in the sample.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The D-dimer (DDMR) method on the Stratus® CS STAT fluorometric analyzer 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 Stratus® CS DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].
Product codes
DAP
Device Description
The Stratus® CS DDMR procedure is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (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 DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer 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 D-dimer molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibody-antigenlabeled 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 D-dimer 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
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
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Summary of Performance Studies
VTE Patients: 832
Cutoff: 450 ng/mL
Key Metrics
Sensitivity: 94%
Specificity: 52%
NPV: 95%
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).
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AUG 1 7 2005
Dade Behring Inc. Stratus® CS D-Dimer 510(k) Notification - Modification
510(k) Summary for Stratus® CS D-Dimer Assay
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.
The assigned 510(k) number is: KD51599
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | |
|---|---|
| --------------- | -- |
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
Contact Information:
Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497 E-mail: kathleen dray-lyons@dadebehring.com
Preparation date:
June 15, 2005 Stratus® CS D-Dimer Assay Device Name/ Classification: Fibrinogen and Fibrin Split Product, Class II, Class: 21 CFR 864.7320 Hematology (HE) Panel: DAP Product Code:
Identification of the Legally Marketed Device: 3.
Stratus® CS D-Dimer (DDMR) Assay (K022976)
Device Description: 4.
The Stratus® CS DDMR procedure is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (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 DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer 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 D-dimer molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibody-antigenlabeled 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 D-dimer 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.
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5. Device Intended Use:
The D-dimer (DDMR) method on the Stratus® CS STAT fluorometric analyzer 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 Stratus® CS DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].
Medical device to which equivalence is claimed and comparison information: 6.
The modified Stratus® CS D-Dimer assay is substantially equivalent to the Stratus® CS D-Dimer currently marketed (K022976). The modified assay. like the current Stratus® CS D-Dimer, is intended for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human citrated or heparinized plasma for use with the Stratus® CS STAT fluourometric analyzer.
7. Device Performance Characteristics:
| VTE
Patients | Cutoff
ng/mL | Sensitivity
(%) | Specificity
(%) | NPV
(%) |
|-----------------|-----------------|--------------------|--------------------|------------|
| 832 | 450 | 94 | 52 | 95 |
Stratus® CS D-Dimer Clinical Study Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
AUG 1 7 2005
K051597 Re:
Trade/Device Name: Stratus® CS D-Dimer (DDMR) Assay Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: II Product Code: DAP Dated: June 15, 2005 Received: June 16, 2005
Dear Ms. Dray-Lyons:
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 (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,
lobetz Beckerh
Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Dade Behring Inc. Stratus® CS D-Dimer 510(k) Notification - Modification
Indications Statement
Device Name:
Stratus® CS D-Dimer (DDMR) Assay
Indications for Use:
The D-dimer (DDMR) method on the Stratus® CS STAT fluorometric analyzer 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 Stratus® CS DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].
Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter-Use_ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051597
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