(41 days)
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No
The summary describes a fluorescence immunoassay and mentions standard analytical performance studies, with no indication of AI/ML technology.
No
The device is an in vitro diagnostic test used for the quantitative determination of D-dimer in blood specimens as an aid in assessing patients suspected of having certain medical conditions. It does not provide any therapy or treatment.
Yes
Explanation: The device is described as "an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events," which indicates its use in diagnosing medical conditions.
No
The device description clearly states it is a "fluorescence immunoassay" and is used with the "Triage® Meter Plus," indicating it is a hardware-based test and meter system, 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 crosslinked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens." This involves testing biological samples in vitro (outside the body).
- Device Description: The description reinforces that it's a "fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens." Again, this describes a test performed on biological samples in vitro.
- Specimen Type: The test uses "EDTA whole blood and plasma specimens," which are biological samples.
- Purpose: The test is used as an "aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism." This indicates a medical purpose based on the analysis of biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Product codes
GHH, DAP
Device Description
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92. The analytical performance characteristics of the assay were equivalent to predicate methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Triage® Profiler S.O.B. Panel (K040437)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
NOV 2 9 2004
510(k) Summary of Safety and Effectiveness
In accordance with the provisions of Section 4 of the Safe Medical Devices Act of 1990 and 21 CFR 807.92, the following summary is provided. Biosite requests that this document be maintained CONFIDENTIAL until such time that the product is cleared by the Food and Drug Administration via the 510(k) process and in accordance with the provisions of the Act.
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 11030 Roselle Street |
| San Diego, CA 92121 | |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | October 14, 2004 |
B. Product
Triage® D-Dimer Test
். Predicate Devices
Triage® Profiler S.O.B. Panel (K040437)
D. Device Description and Intended Use
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
D-dimer is a protein arising directly from the body's natural mechanism to break down blood clots. Elevated levels of D-dimer in a patient's blood are indicative of abnormal rates of increased clot burden. Published studies suggest that D-dimer can be useful in the evaluation of suspected pulmonary embolism (PE).
1
Summary of Comparison Data ட்
A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92. The analytical performance characteristics of the assay were equivalent to predicate methods.
ட் Conclusion
In conclusion, these studies demonstrate the substantial equivalence of the Triage D-Dimer Test to existing products already marketed for detecting the presence and degree of intravascular coagulation and fibrinolysis. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three stripes forming its wing and tail feathers. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 9 2004
Mr. Jeffrey Dahlen Director, Clinical & Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121
Re: K042890
Trade/Device Name: Triage D-Dimer Test Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation product assay Regulatory Class: Class II Product Code: GHH, DAP Dated: November 19, 2004 Received: November 22, 2004
Dear Mr. Dahlen:
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. Ilsting 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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Page 2
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. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Triage D-Dimer Test
Indications For Use:
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Prescription Use (Per 21 CFR 801.109) AND/OR
V
Over-The Counter Use (Per 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)
Jaschiner Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of
510(k) K042890