IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

K030702 · Immco Diagnostics, Inc. · MSV · Sep 9, 2003 · Immunology

Device Facts

• Record ID: K030702
• Device Name: IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: MSV · Immunology
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to β₂-GPI, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythromatosus (SLE) or lupus like disorders.

Device Story

ImmuLisa Anti-β₂ GPI IgM ELISA is a solid-phase immunoassay for human serum samples. Device uses microplates coated with β₂-GPI antigen. Patient serum is incubated in wells; antibodies bind to antigen. Unbound proteins are washed away. Enzyme-labeled anti-human IgM conjugate is added, binding to patient antibodies. After washing, pNPP substrate is added, producing color change proportional to antibody concentration. Reaction is stopped and absorbance measured via spectrophotometer at 405 nm. Used in clinical laboratories by trained personnel. Output is semi-quantitative antibody concentration (EU/mL) used by physicians to assess thrombosis risk in SLE patients.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Solid-phase ELISA; β₂-GPI antigen-coated microwells; Alkaline Phosphatase-labeled anti-human IgM conjugate; p-NPP substrate; spectrophotometric detection at 405 nm. Requires microplate reader. Manual or semi-automated processing. Serum matrix only.

Indications for Use

Indicated for patients with Systemic Lupus Erythromatosus (SLE) or lupus-like disorders to aid in assessing thrombosis risk via detection of IgM antibodies to β₂-GPI.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Mr. Kevin J. Lawson Director, Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Drive Buffalo, New York 14228

SEP - 9 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

k030702 Re: Trade/Device Name: ImmuLisa Anti-Beta2 Glycoprotein I (ß,GP1) IgM ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies, Immunological Test Regulatory Class: II Product Code: MSV Dated: June 16, 2003 Received: August 28, 2003

Dear Mr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

{1}------------------------------------------------

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K Q30 I O Z __

Device Name: ImmuLisa Anti-Beta2 Glycoprotein I (B2GP1) IgM ELISA

- Indications For Use: An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## 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)

/1/07`(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number`K030702