K-ASSAY ALPHA-1 AG

K993441 · Kamiya Biomedical Co. · LKL · Nov 24, 1999 · Immunology

Device Facts

• Record ID: K993441
• Device Name: K-ASSAY ALPHA-1 AG
• Applicant: Kamiya Biomedical Co.
• Product Code: LKL · Immunology
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5420
• Device Class: Class 1

Intended Use

The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. FOR IN VITRO DIAGNOSTIC USE.

Device Story

K-ASSAY Alpha-1 AG is an in vitro diagnostic reagent for quantitative measurement of Alpha-1 acid glycoprotein (Alpha-1 AG) in human serum. Device utilizes immunoturbidimetric assay principle; serum samples are mixed with specific antibodies to form antigen-antibody complexes, causing turbidity proportional to Alpha-1 AG concentration. Turbidity is measured via clinical chemistry analyzer. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing inflammatory conditions, including collagen disorders, tuberculosis, infections, malignancy, and diabetes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay; liquid reagent format; designed for use on automated clinical chemistry analyzers. Measures light absorbance changes resulting from antigen-antibody complex formation.

Indications for Use

Indicated for quantitative determination of Alpha-1 AG in human serum to aid in diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. For in vitro diagnostic use.

Regulatory Classification

Identification

An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 24 1999

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

Re: K993441 Trade Name: K-ASSAY Alpha-1 AG Regulatory Class: II Product Code: LKL Dated: October 5, 1999 Received: October 12, 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 at [phone] 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: K-ASSAY Alpha-1 AG.

## Indications For Use:

The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. 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)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993441 |

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|

OR
Over-The-Counter Use ______
Optional Format 1-2-96)