(48 days)
The K-ASSAY C1-INA Assay is intended for the quantitative determination of human Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema. FOR IN VITRO DIAGNOSTIC USE.
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I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indications for Use Statement" for the K-ASSAY Complement-1 Inactivator (C1-INA) device. This document does not include information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
The information primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls. It does not contain the technical details of the validation studies conducted for the device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
JUL 2 5 2001
K011780 Trade Name: K-ASSAY Complement-1 Inactivator (C1-INA) Regulation Number: 21 CFR § 866.5250 Regulatory Class: II Product Code: DBA Dated: June 7, 2001 Received: June 7, 2001
Dear Mr. Getty:
Re:
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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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 nonication. The PDF mailly ssification 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 additionally 807.10 for mi rias alaguestions on the promotion and advertising of your device, (201) 594-4560. Praditionally, copiliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsionnals 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: K-ASSAY Complement-1 Inactivator (C1-INA).
Indications for Use:
The K-ASSAY C1-INA Assay is ntended for the quantitative determination of human The K-ASSAT CT-INA Assay is Intended for the quint.
Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema.
FOR IN VITRO DIAGNOSTIC USE.
Donald Hoffman
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number_Ko11780
(Please Do NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _
Optional Format 1-2-96)
§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).