ACON STREP A RAPID TEST DEVICE

K031784 · ACON Laboratories, Inc. · GTY · Jul 14, 2003 · Microbiology

Device Facts

• Record ID: K031784
• Device Name: ACON STREP A RAPID TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: GTY · Microbiology
• Decision Date: Jul 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The ACON® Test Device is a rapid Strep A Rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

Device Story

ACON Strep A Rapid Test Device is a lateral flow chromatographic immunoassay; detects Strep A antigen in throat swab specimens. Used in professional and point-of-care settings by healthcare providers. Principle of operation: antigen-antibody binding on a test strip; visual interpretation of colored lines. Provides qualitative results to aid clinical diagnosis of Group A Streptococcal infection. Benefits include rapid turnaround time for infection identification.

Clinical Evidence

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

Technological Characteristics

Lateral flow chromatographic immunoassay; qualitative visual readout. Device consists of a test strip housed in a cassette. No electronic components, software, or external energy source required.

Indications for Use

Indicated for professional and point-of-care use to qualitatively detect Strep A antigen in throat swab specimens to aid in diagnosing Group A Streptococcal infection.

Regulatory Classification

Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing ribbons.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 2003

Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121

k031784 Re:

Trade/Device Name: ACON® Strep A Rapid Test Device Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus Spp. Serological Reagents Regulatory Class: Class I Product Code: GTY Dated: June 9, 2003 Received: June 11, 2003

Dear Dr. Tung:

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 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 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 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). 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 Putman

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 9.

510(k) Number:

K031784

Device Name:

The ACON® Strep A Rapid Test Device

Indications For Use:

The ACON® Test Device is a rapid Strep A Rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-

ﺳﮯ Prescription Use__

(Per 21 CFR 801.109)

Office of In Vitro Diagnostic Device Evaluation and Safety

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

510(k) K031784