AIA-PACK IGE II ASSAY

K972697 · Tosoh Medics, Inc. · DGC · Oct 3, 1997 · Immunology

Device Facts

• Record ID: K972697
• Device Name: AIA-PACK IGE II ASSAY
• Applicant: Tosoh Medics, Inc.
• Product Code: DGC · Immunology
• Decision Date: Oct 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.

Device Story

AIA-PACK IgE II is an in vitro diagnostic assay for quantitative IgE measurement in human serum. Used on TOSOH AIA System analyzers; operated by laboratory personnel in clinical settings. The assay utilizes specific reagents to measure IgE levels; results assist clinicians in diagnosing atopic disorders, allergies, and immune system deficiencies. The device provides numerical output for clinical interpretation.

Technological Characteristics

In vitro diagnostic immunoassay; quantitative measurement of IgE in human serum; designed for use on TOSOH AIA System analyzers.

Indications for Use

Indicated for the quantitative measurement of IgE in human serum to aid in the diagnosis of atopic disorders, allergic conditions, and immune deficiency states.

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

Ms. Lori Robinson Manager, Quality Assurance TOSOH Medics, Inc. 373 D Vintage Park Drive Foster City, California 94404

OCT = 3 1997

Re: K972697 Trade Name: AIA-PACK IqE II Assay Regulatory Class: II Product Code: DGC Dated: July 17, 1997 Received: July 18, 1997

Dear Ms. Robinson:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 requirement, 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 Reqister. 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 Requlations.

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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.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Dutman

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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Page **_ of _**

510(k) Number (if known): \$973697

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## AIA-PACK IGE II Assay

AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madessi

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

**Prescription Use**
(Per 21 CFR 801.109)

2008 A

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)