SAS ADENO TEST

K990630 · Sa Scientific, Inc. · GOD · Aug 19, 1999 · Microbiology

Device Facts

• Record ID: K990630
• Device Name: SAS ADENO TEST
• Applicant: Sa Scientific, Inc.
• Product Code: GOD · Microbiology
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3020
• Device Class: Class 1

Indications for Use

The SAS™ Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

Device Story

SAS™ Adeno Test is a membrane-based immunogold assay for qualitative detection of adenovirus antigens. Input samples include eye swabs, nasal/pharyngeal secretions, fecal samples, and cell culture supernatant. Device utilizes immunogold labeling principle to produce rapid visual results. Intended for professional use in clinical laboratory settings. Provides qualitative detection of adenovirus serotypes to assist healthcare providers in diagnosing adenovirus infections.

Clinical Evidence

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

Technological Characteristics

Membrane-based immunogold assay; qualitative visual detection; in vitro diagnostic device.

Indications for Use

Indicated for professional use for the qualitative detection of adenovirus and adenovirus antigens in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant.

Regulatory Classification

Identification

Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 9 1999

Mr. J. Wessling Regulatory Affairs Coordinator SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240

K990630 Re: Trade Name: SAS™ Adeno Test Regulatory Class: I Product Code: GOD Dated: May 31, 1999 Received: June 2, 1999

Dear Mr. Wessling:

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 Medical 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 laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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## INDICATIONS FOR USE

Applicant:

.

SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240 Ph: [phone] Fax: [phone]

Establishment Reg. No.: 1645225

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: SAS™ Adeno Test

Indication For Use:

The SASTM Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Woody Dubois

Laboratory Devices 990630

Prescription Use

or

Over-the-Counter