QUANTA LITE GBM ELISA

K984336 · Inova Diagnostics, Inc. · MVJ · Feb 8, 1999 · Immunology

Device Facts

• Record ID: K984336
• Device Name: QUANTA LITE GBM ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: MVJ · Immunology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

Device Story

QUANTA Lite™ GBM ELISA is an in vitro diagnostic test used in clinical laboratories. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgG autoantibodies against glomerular basement membrane (GBM) in human serum samples. The assay provides semiquantitative results, which are interpreted by healthcare professionals to assist in the diagnosis of autoimmune renal disorders, specifically Goodpasture's syndrome. The device supports clinical decision-making by identifying the presence of specific autoantibodies, aiding in the differential diagnosis of renal conditions.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for detection of IgG autoantibodies. Semiquantitative measurement. In vitro diagnostic device.

Indications for Use

Indicated for use in human patients suspected of having autoimmune renal disorders, such as Goodpasture's syndrome, to detect IgG class autoantibodies to glomerular basement membrane (GBM) in serum.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

8 1999 FEB

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

Re: K984336 Trade Name: QUANTA Lite™ GBM ELISA Regulatory Class: II Product Code: MVJ Dated: December 2, 1998 Received: December 3, 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 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/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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510(k) Number (if known): 长984336

Device Name: QUANTA Lite™ GBM ELISA

Indications For Use:

A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

Peter E. Malcom

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use