QACA IGG/IGM ELISA KIT

K020241 · Cheshire Diagnostics , Ltd. · MID · Mar 13, 2002 · Immunology

Device Facts

• Record ID: K020241
• Device Name: QACA IGG/IGM ELISA KIT
• Applicant: Cheshire Diagnostics , Ltd.
• Product Code: MID · Immunology
• Decision Date: Mar 13, 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 is an immunoassay for the in vitro semi-quantitative Enzyme Linked Immunosorbent Assay of IgG and IgM antibodies to cardiolipin in human serum.

Device Story

QACA IgG/IgM ELISA Kit is an in vitro diagnostic immunoassay; detects IgG and IgM antibodies to cardiolipin in human serum samples. Principle of operation involves enzyme-linked immunosorbent assay (ELISA) methodology. Used in clinical laboratory settings by trained laboratory personnel. Provides semi-quantitative results to healthcare providers to aid in the assessment of autoimmune conditions associated with anti-cardiolipin antibodies. Results assist clinicians in diagnostic decision-making regarding patient autoimmune status.

Technological Characteristics

In vitro diagnostic immunoassay (ELISA). Semi-quantitative detection of IgG and IgM antibodies. Human serum sample matrix. Standard laboratory equipment required for ELISA processing.

Indications for Use

Indicated for the in vitro semi-quantitative detection of IgG and IgM antibodies to cardiolipin in human serum. For prescription use only.

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/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which may represent people.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 3 2002

Mr. Neil B. Stringer Managing Director Cheshire Diagnostics Limited The Management Centre Inward Way Ellesmere Port Cheshire CH62 3EN

k020241 Re:

Trade/Device Name: QACA IgG/IgM ELISA Kit Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MID Dated: January 22, 2002 Received: January 23, 2002

Dear Mr. Stringer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of togen. J the Medical Device Amendments, or to conimered processified in accordance with the provisions of the Federal Food, Drug, de necs that have been rocasin of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, therefore, mails 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 If your device is classined tools. Existing major regulations affecting your device can may oc subject to back additions, 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has mass and regulations administered by other Federal agencies. You must of any I coural statutes and states and states and limited to: registration and listing (21 comply with an the Fee of equirements, as and manufacturing practice requirements as set

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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 nonlicate 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, (1301) 2) That 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 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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## Indications for Use Statement

Ko20241 510(k) Number:_

Device Name:

QACA IgG/IgM Elisa Kit

Indications for Use: The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit is an The Onoonille Diagmunoassay for the in vitro semi-quantitative Enzyme Einkou of IgG and IgM antibodies to cardiolipin in human serum.

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

Sonsum S. Alta.e

Division Sign-Of Division of Clinics 510(k) Number

Prescription Use ✓ (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)