BIOCHECK IGE ELISA, MODEL BC-1035

K992528 · Biocheck, Inc. · DGC · Sep 21, 1999 · Immunology

Device Facts

• Record ID: K992528
• Device Name: BIOCHECK IGE ELISA, MODEL BC-1035
• Applicant: Biocheck, Inc.
• Product Code: DGC · Immunology
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The BioCheck IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.

Device Story

BioCheck IgE ELISA is an in vitro diagnostic test kit for quantitative measurement of immunoglobulin E (IgE) in human serum. Used in clinical laboratory settings by trained personnel to aid in assessment of hypersensitive and allergic reactions. Principle of operation is enzyme-linked immunosorbent assay (ELISA). Output is quantitative IgE concentration, used by clinicians to evaluate patient allergic status.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for quantitative detection of IgE in human serum. In vitro diagnostic test kit format.

Indications for Use

Indicated for quantitative determination of IgE in human serum to assess hypersensitive and allergic reactions in patients.

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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## SEP 2 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BioCheck, Inc. c/o Ms. Robin J. Hellen Hellen Professional Service 9418 Lasaine Avenue Northridge, California 91325

Re: K992528

> Trade Name: BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA)

Regulatory Class: II Product Code: DGC Dated: July 27, 1999 Received: July 28, 1999

Dear Ms. Hellen:

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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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 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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## lll. Statement for Indications for Use

510(k) Number (if known): K992528

Device Name: *BioCheck, Inc. Immunoglobulin E (IgE)*
*Enzyme Immunoassay Test Kit (IgE-ELISA)*

Indications for Use:

The BioCheck IgE ELISA is intended for the quantitative determination of
immunoglobulin E in human serum. This assay is to be used for the
assessment of hypersensitive and allergic reactions in patients.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

[Signature]
(Division Sign-Off)
Division of Clinical Laboratory Devices K992528
510(k) Number **__**

| Labels | Values |
|-----------------------|-----------------------------|
| Prescription Use: | ✓ |
| Over the Counter Use: | <strong><em>_</em></strong> |
| OR | |