QUANTA LITE RIBOSOME P ELISA

K981237 · Inova Diagnostics, Inc. · MQA · Jun 5, 1998 · Immunology

Device Facts

• Record ID: K981237
• Device Name: QUANTA LITE RIBOSOME P ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: MQA · Immunology
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

An enzyme linked immunosorbant assay (ELISA) for the semiquantitative detection of ribosome P antibody in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

Device Story

QUANTA Lite™ Ribosome P ELISA is an in vitro diagnostic test used to detect ribosome P antibodies in human serum. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology. It is intended for use in clinical laboratory settings by trained personnel to assist physicians in diagnosing systemic lupus erythematosus (SLE) and related connective tissue diseases. The test provides semiquantitative results, which clinicians use alongside clinical symptoms and other diagnostic findings to support a diagnosis. The device aids in identifying patients with specific autoimmune profiles, potentially facilitating earlier diagnosis and management of SLE.

Clinical Evidence

No clinical data provided in the document; the document is a 510(k) clearance letter.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semiquantitative detection of antibodies in human serum. Class II device.

Indications for Use

Indicated for the semiquantitative detection of ribosome P antibody in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and related connective tissue diseases. For prescription use only.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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## JUN 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K981237/S1 QUANTA Lite™ Ribosome P ELISA Trade Name: Requlatory Class: II Product Code: MQA Dated: May 15, 1998 Received: May 19, 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 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, Druq, 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 requirement, 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 Reqister. 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 Requlations.

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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 requlation 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 Putman

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): K98 1237

QUANTA Lite™ Ribosome P ELISA Device Name:

## Indications For Use:

immunosorbant assay (ELISA) for the semilinked An enzyme guantitative detection of ribosome antibody in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

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

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

Tua E. Marlini

(Division Sign-Off)
Division of Clinical Laboratory Devices 14981237
510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)