(302 days)
Not Found
No
The description details a standard immunoassay based on antibody binding and color intensity, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is an in vitro diagnostic assay used to measure d-dimer levels, which can assist in ruling out certain conditions like deep venous thrombosis or pulmonary embolism, but it itself does not provide therapy or treatment.
Yes
Explanation: The device is described as an "Assay" intended for the "quantitative determination of d-dimer" to "rule out deep venous thrombosis or pulmonary embolism," which are diagnostic purposes. The use of the term "diagnostic" or "diagnose" is not required for a device to be considered diagnostic.
No
The device description clearly outlines a physical assay kit and a "Cardiac Reader Instrument," indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of d-dimer in anticoagulated venous whole blood". This involves testing a sample taken from the body (whole blood) in vitro (outside the body) to provide information about a physiological state (d-dimer concentration).
- Device Description: The description details a test that analyzes a biological sample (whole blood) using chemical and immunological reactions to measure a specific analyte (d-dimer). This is a hallmark of an in vitro diagnostic device.
- Predicate Device: The mention of a predicate device (Roche Diagnostics Tina-quant® D-Dimer Test System) with a K number (K002706) strongly indicates that this device is being submitted for regulatory review as an IVD, likely under the 510(k) pathway. Predicate devices are used to demonstrate substantial equivalence for new IVDs.
Therefore, based on the provided information, the CARDIAC D-Dimer Assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cardiac D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the Cardiac Reader Instrument.
Product codes (comma separated list FDA assigned to the subject device)
DAP, GHH
Device Description
The Cardiac D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the Cardiac Reader Instrument. The test is based on the dual monoclonal antibody "sandwich" principle using a poly-(streptavidin)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the Cardiac D-Dimer Assay, which separates red blood cells from plasma. D-Dimer in plasma combines with both biotinylated anti-d-dimer antibody conjugated to gold sol particles, to form a "sandwich". This "sandwich" combines with poly-(streptavidin), which is immobilized in a stripe or line across the read window of the Cardiac D-Dimer Assay, producing a reddish purple line. The intensity and speed at which the color forms are related to the concentration of d-dimer in the blood.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
SEP - 1 2004
| 510(k) Summary | K033491 | |
|---|---|---|
| -- | ---------------- | --------- |
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 |
|---|---|
| Contact Person: Jennifer Tribbett | |
| Date Prepared: August 11, 2004 |
| 2) Device name | |
|---|---|
| Proprietary name: | Cardiac D-Dimer Assay |
| Common name: | D-Dimer |
| Classification name: | Fibrinogen/Fibrin Degradation Product Assay |
| 3) Predicate device | The Roche Diagnostics Cardiac D-Dimer Assay is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostics Tina-quant® D-Dimer Test System (K002706). |
|---|---|
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 4) Device Description | The Cardiac D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the Cardiac Reader Instrument. |
|---|---|
| The test is based on the dual monoclonal antibody "sandwich" principle using a poly-(streptavidin)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the Cardiac D-Dimer Assay, which separates red blood cells from plasma. D-Dimer in plasma combines with both biotinylated anti-d-dimer antibody conjugated to gold sol particles, to form a "sandwich". This "sandwich" combines with poly-(streptavidin), which is immobilized in a stripe or line across the read window of the Cardiac D-Dimer Assay, producing a reddish purple line. The intensity and speed at which the color forms are related to the concentration of d-dimer in the blood. |
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1
| 5) Intended use | The Cardiac D-Dimer Assay is intended for the quantitative determination of
d-dimer in anticoagulated venous whole blood with the Cardiac Reader
Instrument. |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Substantial
equivalence -
Similarities and
Differences | The following tables show the comparison of the Cardiac D-Dimer Assay to
the Tina-quant® D-Dimer Test System. |
| Topic | Tina-quant® D-Dimer Test System
(K002706)
Cardiac D-Dimer Assay |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination D-dimer
in citrated plasma or heparin plasma.
Quantitative determination of d-dimer in
anticoagulated venous whole blood. |
| Test Principle | Latex particles of uniform size are
coated with monoclonal antibodies to
the D-Dimer epitope.
The antigen/antibody complexes
produced by the addition of samples
containing D-Dimer lead to an
increase in the turbidity of the test
reactants. The change in absorbance
with time is dependent on the
concentration of D-Dimer epitopes in
the sample.
The test is based on the dual monoclonal
antibody "sandwich" principle using a
poly-(streptavidin)-biotin capture system
with a gold sol particle label. The test is
initiated by the addition of whole blood
to the Cardiac D-Dimer Assay, which
separates red blood cells from plasma.
D-Dimer in plasma combines with both
biotinylated anti-d-dimer antibody
conjugated to gold sol particles, to form
a "sandwich". This "sandwich"
combines with poly-(streptavidin),
which is immobilized in a stripe or line
across the read window of the Cardiac
D-Dimer Assay, producing a reddish
purple line. The intensity and speed at
which the color forms are related to the
concentration of d-dimer in the blood. |
Continued on next page
2
| Topic | Tina-quant® D-Dimer Test
System (K002706) | Cardiac D-Dimer Assay |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Reagents | •Buffer
•Anti-D-Dimer latex
suspension of
consisting of latex particles
coated with monoclonal anti-
human D-Dimer antibodies
(mouse) | •Buffer
•Biotinylated anti-d-dimer antibody (mouse monoclonal)
•Gold-labeled anti-d-dimer antibody (mouse monoclonal) |
| Measuring
Range | 0.15 - 9.0 ug/ml | 0.1 ug/ml - 4 ug/ml |
| Result Display | Quantitative | Semi-Quantitative |
| | | D-Dimer concentration Display Format |
| | | Less than 0.1 ug/ml "D-Dimer Low" |
| | | Between 0.1 and 4 ug/ml Displays quantitative result |
| | | Greater than 4 ug/ml "D-Dimer High > 4 ug/ml" |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
SEP = 1 2004
K033491 Re:
Trade/Device Name: Cardiac D-Dimer Assay Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrin Degradation Products Regulatory Class: II Product Code: DAP, GHH Dated: August 11, 2004 Received: August 12, 2004
Dear Ms. Tribbett:
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 Mcdical 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 adultcration.
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 Scction 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 yours,
Robert L. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K033491
Device Name: The CARDIAC D-Dimer Assay
Indications For Use:
The CARDIAC D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the CARDIAC Reader instrument.
D-Dimer is a degradation product of crosslinked firbrin. The d-dimer concentration is a measure of the fibrinolytic activity of plasmin in the vascular system. Elevated concentrations of d-dimer indicate increased coagulatory and fibrinolytic activity. In general, a validated d-dimer assay may be useful in ruling out deep venous thrombosis or pulmonary embolism.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Josephine Bautista
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03349/
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