STREP A OIA MAX

K962060 · Biostar, Inc. · GTZ · Jul 23, 1997 · Microbiology

Device Facts

• Record ID: K962060
• Device Name: STREP A OIA MAX
• Applicant: Biostar, Inc.
• Product Code: GTZ · Microbiology
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

Device Story

Strep A OIA MAX is an in vitro diagnostic assay for qualitative detection of Group A Streptococcal antigen. Input: throat swab specimens. Principle: Optical Immunoassay (OIA) technology for rapid identification of Group A Streptococci. Used in clinical laboratory settings by healthcare professionals. Output: visual qualitative result indicating presence or absence of antigen. Assists clinicians in diagnosing streptococcal pharyngitis, facilitating timely treatment decisions.

Clinical Evidence

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

Technological Characteristics

Optical Immunoassay (OIA) technology; qualitative diagnostic assay; manual test format; in vitro diagnostic device.

Indications for Use

Indicated for qualitative detection of Group A Streptococcal antigen in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis to aid in diagnosis of 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUL 23 1997

Roger C. Briden, Ph.D.
Director, Regulatory Affairs and Quality Assurance
BioStar, Inc.
6655 Lookout Road
Boulder, Colorado 80301

Re: K962060
STREP A OIA® MAX
Regulatory Class: I
Product Code: GTZ
Dated: June 17, 1997
Received: June 18, 1997

Dear Dr. Briden:

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 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 requirement, 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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) Number (if known): K962060

Device Name: Strep A OIA® MAX

Indications For Use:

The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for *in vitro* diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K962060

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)