SYNTHETIC VDRL ANTIGEN

K993633 · Centers for Disease Control and Prevention · GMQ · Feb 23, 2000 · Microbiology

Device Facts

• Record ID: K993633
• Device Name: SYNTHETIC VDRL ANTIGEN
• Applicant: Centers for Disease Control and Prevention
• Product Code: GMQ · Microbiology
• Decision Date: Feb 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3820
• Device Class: Class 2

Intended Use

Synthetic Venereal Disease Research Laboratory (VDRL) antigen is intended for use in the qualitative and quantitative VDRL slide tests for the detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid of persons with syphilis.

Device Story

Synthetic VDRL antigen is an in vitro diagnostic reagent used in slide tests to detect nontreponemal antibodies (IgM and IgG) associated with syphilis. The device is intended for use by clinical laboratory professionals. It functions as a reagent in standard VDRL slide test protocols, where the presence of antibodies is indicated by flocculation. Results assist clinicians in the diagnosis of syphilis infection. The device is used in clinical laboratory settings.

Technological Characteristics

Synthetic VDRL antigen reagent for use in qualitative and quantitative slide tests. Class II device, product code GMQ.

Indications for Use

Indicated for the qualitative and quantitative detection of IgM and IgG nontreponemal antibodies in serum or cerebrospinal fluid to aid in the diagnosis of syphilis.

Regulatory Classification

Identification

Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 2 3 2000

Victoria Pope, Ph.I). Chief, Syphilis Diagnostic Activity Centers for Disease Control 1600 Clifton Road, N.E. Atlanta, Georgia 30333

Re: K993633 Trade Name: Synthetic VDRL Antigen Regulatory Class: II Product Code: GMQ Dated: January 14, 2000 Received: January 24, 2000

Dear Dr. Pope:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Mcdical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Tave For regulations.

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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 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Public Health Service

Centers for Disease Control and Prevention (CDC) Allanta (GA 30333

Indication for Use.

510(k) Number: K993633 Device Name: Synthetic VDRL Antigen

Synthetic Venereal Disease Research Laboratory (VDRL) antigen is intended for use in the qualitative and quantitative VDRL slide tests for the detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid of persons with syphilis.

Woody Dubois

(Division Sign-Off) Division of Chical Laboratory Devices 510(k) Number 199363

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)