BIOSTREP A-DIRECT STREP A ANTIGEN TEST

K983386 · Princeton BioMeditech Corp. · GTY · Nov 25, 1998 · Microbiology

Device Facts

• Record ID: K983386
• Device Name: BIOSTREP A-DIRECT STREP A ANTIGEN TEST
• Applicant: Princeton BioMeditech Corp.
• Product Code: GTY · Microbiology
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The BioStrep® A is intended for use as an in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.

Device Story

BioStrep® A is an in vitro diagnostic test for qualitative detection of group A streptococcal antigen. Input: throat swab specimens. Operation: lateral flow immunoassay (implied by product type). Output: visual qualitative result indicating presence or absence of antigen. Used in physician offices, hospitals, and clinical laboratories by healthcare professionals. Assists clinicians in diagnosing group A streptococcal infections to guide treatment decisions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test for qualitative antigen detection. Form factor: throat swab test kit. Intended for professional use in clinical settings.

Indications for Use

Indicated for qualitative detection of group A streptococcal antigen in throat swab specimens to aid in clinical diagnosis of group A streptococcal infection in patients in physician offices, hospitals, and clinical laboratories.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 2 5 1998

Jemo Kang, Ph.D. President Princeton BioMeditech Corp. 4242 U.S. Rt. 1 Monmouth Junction. NJ 08852

Re: K983386 Trade Name: BioStrep® A Regulatory Class: I Product Code: GTY Dated: September 24, 1998 Received: September 26, 1998

## Dear Dr. Kang:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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510(k) Notification - BioStrep® A Princeton BioMeditech Corporation

510(k) Number (if Known) : Not Known at this time

Device Name : BioStrep® A

Indications for Use:

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The BioStrep® A is intended for use as an in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.

Woody Dubois

Division of Clinical Laboratory Devices 510(k) Number_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional Use X

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)