REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

K034013 · Corgenix, Inc. · LKJ · Jan 8, 2004 · Immunology

Device Facts

• Record ID: K034013
• Device Name: REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
• Applicant: Corgenix, Inc.
• Product Code: LKJ · Immunology
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The REAADS Anti-DsDNA Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of IgG anti-dsDNA antibodies in human serum. The assay is intended for use as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).

Device Story

REAADS® Anti-dsDNA Quantitative Test Kit is an in vitro diagnostic assay; detects and quantitates anti-dsDNA antibodies in human serum. Used in clinical laboratory settings by trained laboratory personnel. Principle of operation involves enzyme-linked immunosorbent assay (ELISA) technology. Input is patient serum sample; output is quantitative concentration of anti-dsDNA antibodies. Results assist clinicians in the diagnosis and management of systemic lupus erythematosus (SLE).

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for the detection of anti-dsDNA antibodies. Class II medical device, product code LKJ, regulated under 21 CFR 866.5100.

Indications for Use

Indicated for the quantitative determination of IgG anti-dsDNA antibodies in human serum as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JAN - 8 2004

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Ms. Nanci Dexter Director, Quality and Regulatory Corgenix, Inc. 12061 Tejon Street Westminister, CO 80234

k034013 Re: Trade/Device Name: REAADS® Anti-dsDNA Quantitative Test Kit Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test systems Regulatory Class: Class II Product Code: LKJ Dated: December 22, 2003 Received: December 23, 2003

Dear Ms, Dexter:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answer in 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, de vices that mave been 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 r lease of advised that I Drisean 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 I 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).

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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.

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 Dutman

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

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Indications for Use Statement

510(k) Number: K034013

Device Name: REAADS® Anti-dsDNA Quantitative Test Kit Indications for Use:

For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).

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

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)

Mana M. Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03 4013