HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI

K991820 · Zeus Scientific, Inc. · LYR · Aug 12, 1999 · Microbiology

Device Facts

• Record ID: K991820
• Device Name: HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
• Applicant: Zeus Scientific, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.

Device Story

Enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgG antibodies to Helicobacter pylori; performed in clinical laboratory settings by trained personnel. Input: human serum samples. Principle: antigen-antibody reaction; colorimetric detection. Output: qualitative result (positive/negative) indicating presence of IgG antibodies. Assists clinicians in diagnosing H. pylori infection in symptomatic adult patients.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) test system for in vitro diagnostic use. Qualitative detection of IgG antibodies.

Indications for Use

Indicated for qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. For in vitro diagnostic use.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 12 1999

Mr. Mark J. Kopnitsky Vice President Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, New Jersey 08869

K991820 Re:

> Trade Name: Helicobacter pylori IgG ELISA · Test System Regulatory Class: I Product Code: LYR Dated: May 19, 1999 Received: May 27, 1999

Dear Mr. Kopnitsky:

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 Butman

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 1 of 1

510(k) Number (if known): __

## Device Name: Helicobacter pylori IgG ELISA Test System

Indications for Use:

## Helicobacter pylori IgG ELISA Test System; 3Z512021G

.. .

The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.

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Woody Dubois

Concurrence of CDRH, Office of Device Evaluation (ODE)

inical Laboratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801, 108)

OR

Over-The-Counter Use

(Optional Format 1-2-96)