QACA IGG/IGM ELISA KIT HRP

K021192 · Cheshire Diagnostics , Ltd. · MID · May 16, 2002 · Immunology

Device Facts

• Record ID: K021192
• Device Name: QACA IGG/IGM ELISA KIT HRP
• Applicant: Cheshire Diagnostics , Ltd.
• Product Code: MID · Immunology
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum. The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.

Device Story

QACA IgG/IgM Elisa Kit HRP is an enzyme-linked immunosorbent assay (ELISA) for detecting anti-cardiolipin antibodies in human serum. Used in clinical laboratory settings by trained personnel. Input: human serum sample. Process: antigen-antibody binding reaction; horseradish peroxidase (HRP) conjugate detection; colorimetric measurement. Output: semiquantitative antibody levels. Results interpreted by clinicians alongside other serological tests and clinical findings to assess thrombosis risk in SLE patients.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the ELISA assay.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) utilizing HRP-conjugated antibodies for detection. Semiquantitative colorimetric measurement. In vitro diagnostic device.

Indications for Use

Indicated for in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum to aid in thrombosis risk assessment for patients diagnosed with Systemic Lupus Erythematosus (SLE) or lupus-like disorders.

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 1 6 2002

Mr. Neil B. Stringer Managing Director Cheshire Diagnostics Limited The Management Centre Inward Way, Ellesmere Port Cheshire, CH65 3EN England

k021192 Re:

Trade/Device Name: QACA IgG/IgM Elisa Kit HRP Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MID Dated: April 11, 2002 Received: April 15, 2002

Dear Mr. Stringer:

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 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.

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 Part 801); 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.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

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) QACA IgG/IgM Elisa Kit HRP

## Indications for Use Statement

510(k) Number: K 021/92

Device Name:

QACA IgG/IgM Elisa Kit HRP

Indications for Use: The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.

> The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sousan S. Altaie

(Division Sign-Off) Division of Clinical Laborato 510(k) Number

Prescription Use v (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)