QUANTA LITE H. PYLORI IGG ELISA

K982790 · Inova Diagnostics, Inc. · LYR · Nov 4, 1998 · Microbiology

Device Facts

• Record ID: K982790
• Device Name: QUANTA LITE H. PYLORI IGG ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The QUANTA Lite™ H. pylori IgG kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera. This test is intended to aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease. This test is for in vitro diagnostic use.

Device Story

QUANTA Lite™ H. pylori IgG ELISA is an in vitro diagnostic test; utilizes enzyme-linked immunosorbent assay (ELISA) technology; detects IgG antibodies to H. pylori in human serum samples. Performed in clinical laboratory settings by trained personnel. Provides qualitative results to assist clinicians in diagnosing H. pylori infections in symptomatic adult patients. Results interpreted by healthcare providers in conjunction with clinical presentation to guide patient management and treatment decisions.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgG antibodies. In vitro diagnostic device.

Indications for Use

Indicated for qualitative detection of IgG antibodies to H. pylori in adult patient sera to aid in diagnosis of H. pylori infection in patients with clinical signs/symptoms of gastrointestinal disease.

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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4 1998 NOV

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, CA 92131-1234

Re: K982790

> Trade Name: QUANTA Lite™ H. pylori IgG ELISA Regulatory Class: I Product Code: LYR Dated: October 9, 1998 Received: October 13, 1998

Dear Mr. Myers:

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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Page of of

482790 510(k) Number (if known):

Device Name: QUANTA Lite™ H. pylori IgG ELISA

Indications For Use:

Lite™ H. pylori IgG kit is an The QUANTA enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IqG antibodies to H. pylori (Helicobacter pylori) in patient sera. This test is intended to aid in the diaqnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease. This test is for in vitro diaqnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

DKnight for Wendy Dubois

(Division Sign-
Division of Chi. i Laboratory Devices
510(k) Number K982790

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

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