EL-B2GP1SCR

K973882 · Theratest Laboratories, Inc. · MSV · Dec 5, 1997 · Immunology

Device Facts

• Record ID: K973882
• Device Name: EL-B2GP1SCR
• Applicant: Theratest Laboratories, Inc.
• Product Code: MSV · Immunology
• Decision Date: Dec 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The TheraTest EL-B2GP1scr is an in vitro diagnostic tests for the screening for autoantibodies in human serum directed against the serum glycoprotein ß 2 Glycoprotein 1 (ß2GP1) . This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Device Story

EL-B2GP1scr is an in vitro diagnostic test; screens human serum for autoantibodies against ß2-glycoprotein 1 (ß2GP1). Used in clinical laboratory settings; aids physicians in diagnosing antiphospholipid antibody syndrome (APS) or autoimmune thrombotic disorders (e.g., secondary to systemic lupus erythematosus). Provides qualitative or semi-quantitative results to support clinical decision-making regarding autoimmune pathology.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test; enzyme-linked immunosorbent assay (ELISA) format for detection of autoantibodies against ß2GP1 in human serum.

Indications for Use

Indicated for in vitro screening of human serum for autoantibodies against ß2-glycoprotein 1 (ß2GP1) to aid in diagnosing antiphospholipid antibody syndrome (APS) or autoimmune thrombotic disorders secondary to systemic lupus erythematosus.

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

DEC - 5 1997

Marius Teodorescu, M.D., Ph.D. President and CEO TheraTest Laboratories, Inc. 2201 W. Campbell Park Drive Chicago, Illinois 60612-3501

Re: K973882 The TheraTest EL-B2GP1 Scr Trade Name: Regulatory Class: II Product Code: MSV Dated: October 10, 1997 Received: October 14, 1997

Dear Dr. Teodorescu:

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, labelinq, 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 requlation (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 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 yitro 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 Autman

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) K973882 Device Name: EL-B2GP1Scr

Indications for Use: The TheraTest EL-B2GP1scr is an in vitro diagnostic tests for the screening for autoantibodies in human serum directed against the serum glycoprotein ß 2 Glycoprotein 1 (ß2GP1) . This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

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Concurrence of CDRH, Office of Device Evaluation (QDE)

| | <img alt="Signature" src="signature.png"/> |
|-----------------------------------------|--------------------------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K973882 |

| Prescription use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter use |
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