(168 days)
Not Found
Not Found
No
The summary describes a latex assay for fibrin derivatives, a standard laboratory test, and contains no mention of AI or ML.
No
The device is described as an "assay" intended for rapid qualitative or semi-quantitative evaluation, which indicates it's a diagnostic tool, not a therapeutic one. It analyzes circulating derivatives in human plasma, which is for diagnostic purposes, not treatment.
Yes
The device is intended for the "rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma," which indicates it is used to assess a patient's biological markers for diagnostic purposes.
No
The device is a laboratory assay intended for the evaluation of human plasma, which implies the use of physical reagents and laboratory equipment, not solely software.
Based on the provided information, the Dimertest Latex Assay is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma." This indicates the device is used to test a biological sample (human plasma) in vitro (outside the body) to obtain information about a person's health status.
The definition of an IVD device typically involves testing samples taken from the human body to provide information for diagnosis, monitoring, or screening. The description perfectly aligns with this.
N/A
Intended Use / Indications for Use
The Dimertest Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma.
Product codes
DAP
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 6 1998
Russell Richards · Director, Regulatory and Market Support AGEN Biomedical Limited 11 Durbell Street P.O. Box 391 Acacia Ridge, Qld 4110 Australia
Re : K974596 Dimertest Latex Assay Regulatory Class: II Product Code: DAP Dated: March 17, 1998 Received: April 2, 1998
Dear Mr. Richards:
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 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 The general controls provisions of the Act 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 requlations 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Steven Litman
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
2
Pageof
510(k) Number (if known): めぐイイ5 %
Device Name:_
Indications For Use:
AGEN Biomedical Ltd Attachment C, Page 1
Dimertest Latex Assay Device Name:
The Dimertest Latex Assay is intended for the rapid qualitative Intended Use: or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974596
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)