(114 days)
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Not Found
No
The summary describes a standard in vitro diagnostic assay based on immunoturbidimetry, with no mention of AI or ML in the intended use, device description, or other sections.
No
Explanation: The device is described as an "in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products," making it an in vitro diagnostic (IVD) device, not a therapeutic device. It is used to diagnose or monitor a condition, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the K-ASSAY® D-Dimer Assay is "an in vitro diagnostic reagent" and its purpose is "for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay," which is a diagnostic function.
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent..."
- "The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent..."
- "For in vitro diagnostic use."
These statements clearly indicate that the device is intended for use outside of the body to examine specimens from the human body for the purpose of providing information for diagnosis.
N/A
Intended Use / Indications for Use
The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.
The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay.
For in vitro diagnostic use.
Product codes
DAP, 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): 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.
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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.
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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).
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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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, with three wavy lines below them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 7 2003
Mr. Brian Schliesman Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, WA 98188
Re: K030687
Trade/Device Name: K-Assay® D-Dimer Immunoturbidimetric Assay and K-Assay® D-Dimer Immunoturbidimetric Calibrator Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP: GHH Dated: June 5, 2003 Received: June 5, 2003
Dear Mr. Schliesman:
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, 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 (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).
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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.
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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
K-ASSAY® D-Dimer Immunoturbidimetric Assay and Device Name: K-ASSAY® D-Dimer Calibrator
Indications For Use:
The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.
The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay.
For in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division Diagnostic Device of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
In September of Sefety Office of in and Safety
Evaluation and Safety
510(k) K030687
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Format 1-2-96)