(148 days)
Not Found
No
The description details a turbidimetric assay based on antibody agglutination, a standard laboratory technique. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a diagnostic test for measuring D-dimer levels and monitoring coagulation, not a therapeutic device designed to treat a condition.
Yes
The device aids in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation, which are diagnostic purposes.
No
The device description clearly outlines a laboratory test involving physical components (polystyrene particles, monoclonal antibody) and a chemical reaction (agglutination detected turbidimetrically). This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body).
- Device Description: The description details a laboratory test using polystyrene particles and antibodies to detect a substance (D-dimer) in a sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies describe comparisons to another assay and precision testing, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K862156 Asserachrom® D-Di) which is also an IVD, further supports that this device falls under the IVD category.
The core function of the device is to analyze a biological sample (human plasma) to provide information about a patient's health status (presence and degree of intravascular coagulation and fibrinolysis), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with a Dade Behring Coagulation Analyzer.
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids 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).
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the cross-linkage region of cross-linked fibrin degradation products containing D-dimer are agglutinated when mixed with samples containing D-dimer. The cross-linkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an agglutination reaction, which is then detected turbidimetrically via the increase in turbidity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
Correlation: The Advanced D-Dimer assay was compared to the Asserachrom® D-Di by evaluating 316 samples ranging from 0.43 to 85.9 mg/l. A correlation coefficient of 0.91 was obtained, with a y-intercept value of 0.54 and a slope of 0.98.
Precision: Precision studies were performed by the evaluation of two levels of control material and two levels of human plasma pools in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 0.8 to 3.8%, while the intra-assay precision ranged from 1.3 to 3.0%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 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
Advanced D-Dimer 510(k) Notification K992957 Additional Information
510(k) Summary for Advanced D-Dimer
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: _____________________________
Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
Marburg/Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
Glasgow Site
P.O. Box 6101
Newark, Delaware 19714
Attn: Rebecca S. Ayash
Tel: 302-631-6276 |
| Preparation date: | December 3, 1999 |
Device Name/ Classification: 2.
| Advanced D-Dimer: | Fibrinogen/fibrin degradation products assay |
|---|---|
| Classification Number: | Class II (864.7320) |
ldentification of the Legally Marketed Device: 3.
Asserachrom® D-Di (K862156)
4. Device Description:
Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products containing D-dimer are agglutinated when mixed with samples containing D-dimer. The cross-linkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an agglutination reaction, which is then detected turbidimetrically via the increase in turbidity.
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5. Device Intended Use:
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with a Dade Behring Coagulation Analyzer.
Medical device to which equivalence is claimed and comparison information: 6.
There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma. One such product is the Asserachrom® D-Di (K862156). Advanced D-Dimer is substantially equivalent in intended use and results obtained to the Asserachrom® D-Di. The Advanced D-Dimer, like Asserachrom® D-Di is intended to be used for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in human plasma.
7. Device Performance Characteristics:
Correlation:
The Advanced D-Dimer assay was compared to the Asserachrom® D-Di by evaluating 316 samples ranging from 0.43 to 85.9 mg/l. A correlation coefficient of 0.91 was obtained, with a y-intercept value of 0.54 and a slope of 0.98.
Precision:
Precision studies were performed by the evaluation of two levels of control material and two levels of human plasma pools in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 0.8 to 3.8%, while the intra-assay precision ranged from 1.3 to 3.0%.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
JAN 2 8 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca S. Avash Manager, Regulatory Affairs, Biology Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
Re: K992957 Trade Name: Advanced D-Dimer Regulatory Class: II Product Code: DAP Dated: December 3, 1999 Received: December 6, 1999
Dear Ms. Ayash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Advanced D-Dimer 510(k) Notification K992957 Additional Information
Indications Statement
Device Name: Advanced D-Dimer
Indications for Use:
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids 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).
Otto G. Macion
(Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number --
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)