IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS

K113020 · Immco Diagnostics, Inc. · MID · Oct 25, 2012 · Immunology

Device Facts

• Record ID: K113020
• Device Name: IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
• Applicant: Immco Diagnostics, Inc.
• Product Code: MID · Immunology
• Decision Date: Oct 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

ImmuLisa Enhanced™ Cardiolipin IgA Antibody (ACA) ELISA: Enzyme linked immunoassays (ELISAs) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ Cardiolipin IgG Antibody (ACA) ELISA: Enzyme linked immunoassays (ELISAs) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ Cardiolipin IgM Antibody (ACA) ELISA: Enzyme linked immunoassays (ELISAs) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ Cardiolipin Antibody IgA/IgG/IgM Antibody (ACA) ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Device Story

Microwell-based ELISA assays for detection of IgG, IgM, and IgA antibodies to Cardiolipin in human serum. Device uses polystyrene plates coated with Cardiolipin antigen and Beta-2 glycoprotein 1 (β2GP1). Patient serum samples, calibrators, and controls are added to wells; specific antibodies bind to immobilized antigen. Unbound material is washed away; HRP-conjugated anti-human IgG/IgA/IgM is added. After secondary wash, TMB substrate is added, producing color change proportional to antibody concentration. Reaction stopped with H2SO4; absorbance measured at 450 nm via spectrophotometer. Results expressed in U/mL (APL, GPL, MPL) or EU/mL. Used in clinical laboratories by trained personnel to support diagnosis of APS and SLE-associated APS. Output aids clinicians in confirming autoimmune conditions; results interpreted alongside clinical history and other diagnostic tests.

Clinical Evidence

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

Technological Characteristics

Microwell ELISA; polystyrene plates coated with purified Cardiolipin (1,1',2,2' Tetraoleoyl Cardiolipin) and human/bovine β2GP1. Energy source: spectrophotometer (450 nm). Reagents: HRP-conjugated goat anti-human IgG/IgA/IgM, TMB substrate, H2SO4 stop solution. Manual or automated processing. Stability: 18-month shelf life (accelerated), 30-day open-kit stability. Standards: CLSI EP06-A, EP07-A2, EP09-A2, EP12-A2, EP17-A, EN 13640.

Indications for Use

Indicated for qualitative or semi-quantitative detection of Cardiolipin IgA, IgG, and IgM antibodies in human serum to aid in diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE). For use in conjunction with other clinical findings and laboratory tests.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure.

## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

OCT 25 2012

IMMCO Diagnostics, Inc. c/o Mr. Kevin J. Lawson VP Regulatory Affairs 60 Pineview Drive, Buffalo, NY 14228

Re: k113020

Trade/Device Name: ImmuLisa Enhanced™ Cardiolipin IgA Antibody (ACA) ELISA ImmuLisa Enhanced™ Cardiolipin IgG Antibody (ACA) ELISA ImmuLisa Enhanced™ Cardiolipin IgM Antibody (ACA) ELISA ImmuLisa Enhanced™ Cardiolipin IgA/IgG/IgM Antibody (ACA) ELISA

Regulation Number: 21 CFR §866.5660

Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID Dated: October 23, 2012 Received: October 24, 2012

#### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Kevin Lawson

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 or any is all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

ia m chan

Maria M. Chan, Ph.D. Director Division Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K113020

ImmuLisa Enhanced™ Cardiolipin IgA Antibody (ACA) Device Name: ELISA

Enzyme linked immunoassay (ELISA) for the qualitative or Indications For Use: semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

NZP Nizan Panyon
Division Sign-Off

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safaty

510K k113020

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510(k) Number (if known): K113020

Device Name:

ImmuLisa Enhanced ™ Cardiolipin IgG Antibody (ACA) ELISA

Indications For Use:

Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

NZF Ntar Samper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510K k113020

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510(k) Number (if known): K113020

ImmuLisa Enhanced™ Cardiolipin IgM Antibody (ACA) ELISA

Indications For Use:

Device Name:

Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

NZP Nisar Rampen

---

Initials Sign-Off

Division Sign-C

Office of In Vitro Diagnostic Omce of Interest and Safet

518K K11302 J

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510(k) Number (if known): K113020

Device Name:

ImmuLisa Enhanced ™ Cardiolipin IgA/IgG/IgM Antibody (ACA) ELISA

Indications For Use: Enzyme linked immunoassay (ELISA) for the qualitative : detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

NZP Nisar Ramyr

Division Sig

Office of In Vitro Diagnost Office Evaluation and

Device
510K K113020