K-ASSAY C4

K993481 · Kamiya Biomedical Co. · DBI · Nov 29, 1999 · Immunology

Device Facts

• Record ID: K993481
• Device Name: K-ASSAY C4
• Applicant: Kamiya Biomedical Co.
• Product Code: DBI · Immunology
• Decision Date: Nov 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human serum. Complement is a group of serum proteins which destroy foreign cells. Measurement of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

Device Story

K-ASSAY C4 is an in vitro diagnostic reagent for quantitative measurement of C4 protein in human serum. Used in clinical laboratory settings by trained personnel. Principle of operation involves immunoturbidimetric assay to detect complement component levels. Output is a quantitative concentration value used by clinicians to assess immunological status and diagnose disorders related to complement deficiencies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay for quantitative determination of C4 in human serum. In vitro diagnostic reagent.

Indications for Use

Indicated for the quantitative determination of C4 in human serum to aid in the diagnosis of immunological disorders, particularly those associated with complement component deficiencies.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 300 1999

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

K993481 Re: Trade Name: K-ASSAY C4 Regulatory Class: II

Product Code: DBI 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 OS 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

4993481 510(k) Number (if known): __

Device Name: K-ASSAY C4.

## Indications for Use:

The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human r no A ACON - O Tributy load Complement is a group of serum proteins which destroy scraft by inmunotarelained at these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993481 |

| Prescription Use | <img alt="prescription use" src="prescription_use.png"/> | OR | Over-The-Counter Use ______ |
|----------------------|----------------------------------------------------------|----|-----------------------------|
| (Per 21 CFR 801.109) | | | |

Optional Format 1-2-96