K-ASSAY C1-INA

K011780 · Kamiya Biomedical Co. · DBA · Jul 25, 2001 · Immunology

Device Facts

• Record ID: K011780
• Device Name: K-ASSAY C1-INA
• Applicant: Kamiya Biomedical Co.
• Product Code: DBA · Immunology
• Decision Date: Jul 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5250
• Device Class: Class 2

Intended Use

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.

Device Story

K-ASSAY C1-INA is an in vitro diagnostic assay for quantitative measurement of Complement-1 Inactivator (C1-INA) in human plasma. Operates via immunoturbidimetric principle; utilizes antigen-antibody reaction to measure turbidity changes proportional to C1-INA concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing hereditary angioedema. Provides objective data for patient management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench-top performance characteristics of the immunoturbidimetric assay.

Technological Characteristics

Immunoturbidimetric assay; measures turbidity changes resulting from antigen-antibody complex formation. In vitro diagnostic reagent kit. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the quantitative determination of human Complement-1 Inactivators in human plasma to aid in the diagnosis of hereditary angioedema.

Regulatory Classification

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).

Submission Summary (Full Text)

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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 stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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, [phone]. Praditionally, copiliance at [phone]. 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 [phone] or [phone] 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)