K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

K042241 · Kamiya Biomedical Co. · DGC · Dec 10, 2004 · Immunology

Device Facts

• Record ID: K042241
• Device Name: K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
• Applicant: Kamiya Biomedical Co.
• Product Code: DGC · Immunology
• Decision Date: Dec 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The Kamiya K-Assay® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The Kamiya K-Assay® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the Kamiya K-Assay® Total IgE Assay.

Device Story

K-ASSAY® Total IgE Assay is an in vitro diagnostic reagent kit utilizing immunoturbidimetric technology; measures circulating total IgE levels in human serum or plasma samples. Operates on automated clinical chemistry analyzers; reagents react with IgE in patient samples to produce turbidity proportional to IgE concentration. Output is quantitative IgE measurement used by clinicians to assist in diagnosing IgE-mediated allergic conditions. Intended for professional laboratory use; results interpreted alongside patient history and clinical findings.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the immunoturbidimetric assay.

Technological Characteristics

Immunoturbidimetric assay. Reagents: Tris HCl buffer and latex particles coated with goat anti-human IgE. Energy source: optical (570 nm light scattering). Platform: Roche Hitachi 917 analyzer. Calibration: 6-level human serum-based calibrators traceable to 2nd WHO International Reference Preparation (NIBSC 75/502).

Indications for Use

Indicated for quantitative determination of total IgE in human serum or plasma to aid in clinical diagnosis of IgE-mediated allergic disorders. Prescription use only.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 0 2004

Kamiya Biomedical Co. c/o Mr. Brian Schliesman 12779 Gateway Dr. Seattle, WA 98168

Re: k042241

Trade/Device Name: K-Assay® Total IgE Assay K-Assay® IgE Calibrator Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: DGC, JIT Dated: August 17, 2004 Received: September 7, 2004

Dear Mr. Schliesman:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Brian Schliesman

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K04224 / /

K-ASSAY® Total IgE Assay and Device Name: K-ASSAY® IgE Calibrator Set

Indications For Use:

The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay.

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)

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K04224/

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Optional Format 1-2-96)

IgE 510 (k), KAI-092 KAMIYA BIOMEDICAL COMPANY 11/2004

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