QUANTA LITE B2GPI IGG

K970551 · Inova Diagnostics, Inc. · MSV · Jun 24, 1997 · Immunology

Device Facts

• Record ID: K970551
• Device Name: QUANTA LITE B2GPI IGG
• Applicant: Inova Diagnostics, Inc.
• Product Code: MSV · Immunology
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

A semiquantitative enzyme linked immunoassay for detecting IgG class autoantibody to β₂ glycoprotein I (β₂ GPI) for use as an aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus or other lupus like thrombotic diseases.

Device Story

QUANTA Lite™ β₂GPI IgG is a semiquantitative enzyme-linked immunosorbent assay (ELISA) kit. It detects IgG autoantibodies against β₂ glycoprotein I in human serum. Used in clinical laboratory settings by trained personnel. The assay involves binding patient serum to β₂GPI-coated wells; captured IgG is detected via enzyme-conjugated anti-human IgG and a colorimetric substrate. Results are interpreted by clinicians to support the diagnosis of autoimmune-related thrombotic disorders. The device provides objective immunological data to assist in clinical decision-making for patients with suspected systemic lupus erythematosus or related conditions.

Clinical Evidence

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

Technological Characteristics

ELISA (Enzyme-Linked Immunosorbent Assay) format. Utilizes β₂ glycoprotein I antigen-coated microplate wells. Detection via enzyme-conjugated anti-human IgG and colorimetric substrate. Semiquantitative measurement of IgG autoantibodies.

Indications for Use

Indicated for patients suspected of having autoimmune disease thrombotic disorders, including those secondary to systemic lupus erythematosus or lupus-like conditions. For professional use as an aid in diagnosis.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUN 24 1997

Brys Myers
INOVA Diagnostics, Inc.
10451 Roselle Street
San Diego, CA 92121

Re: K970551/S001
Trade Name: QUANTA Lite™ Beta 2 GPI IgG ELISA
Regulatory Class: II
Product Code: MSV
Dated: May 02, 1997
Received: May 05, 1997

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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].

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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 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): K970551

Device Name: QUANTA Lite™ β₂GPI IgG

## Indications For Use:

A semiquantitative enzyme linked immunoassay for detecting IgG class autoantibody to β₂ glycoprotein I (β₂ GPI) for use as an aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus or other lupus like thrombotic diseases.


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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)