(75 days)
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No
The description focuses on a rapid immunochromatography test, which is a traditional in vitro diagnostic method, and there is no mention of AI or ML in the provided text.
No
Explanation: This device is an in vitro diagnostic test intended to aid in diagnosis, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" states that the test is "intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism."
No
The device description clearly states it is a "rapid immunochromatography test," which is a physical test kit involving reagents and a test strip, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of D-dimer... in human whole blood and plasma." This involves testing biological samples taken from the human body.
- Purpose: The test is intended "for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism." This indicates it's used to provide information about a person's health status based on the analysis of these samples.
- Device Description: The description confirms it's a "rapid immunochromatography test for the qualitative detection of D-dimer... in human whole blood and plasma." This further reinforces its nature as a test performed on biological samples.
These characteristics align perfectly 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 compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.
Product codes
GHH
Device Description
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
DEC I 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Russell Richards Director, Regulatory Affairs and International Market Support Agen Biomedical Limited 11 Durbell Street, P.O. Box 391 Acacia Ridge, Brisbane Queensland 4110 AUSTRALIA
Re: K993276 Trade Name: Simplify™ D-dimer Regulatory Class: II Product Code: GHH Dated: September 23, 1999 Received: September 30, 1999
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 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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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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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| 510(k) Number (if known): | K993276 |
|---|---|
| --------------------------- | --------- |
SIMPLIFY D-DIMER Device Name: _
Indications For Use:
The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Makin
(Division Sign-Off) Division of Clinical Laboratory Devices KG327 510(k) Number
Prescription Use रे (Pcr 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)