(53 days)
The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.
Not Found
The provided text details an FDA 510(k) clearance for the K-ASSAY Fibrinogen device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document is a clearance letter from the FDA to Kamiya Biomedical Company, stating that their K-ASSAY Fibrinogen device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory class, product code, and marketing permissions. The "Indications for Use Statement" simply describes what the device is intended for (determining fibrinogen levels in disseminated intravascular coagulation and primary fibrinolysis for in vitro diagnostic use).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 6 1999
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K993482 Re: Trade Name: K-ASSAY Fibrinogen Regulatory Class: II Product Code: GIS Dated: October 11, 1999 Received: October 14, 1999
Dear Mr. Getty:
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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INDICATIONS FOR USE STATEMENT
K993482-510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: K-ASSAY Fibrinogen.
Indications for Use:
The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Øffice of Device Evaluation (ODE) wision Sign-Off) Division of Clinical Laboratory Gevices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) Optional Format 1-2-96)
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.