(60 days)
Not Found
Not Found
No
The summary describes a qualitative in vitro diagnostic test for detecting streptococcal antigen, which is a chemical/biological assay and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is an in vitro diagnostic product designed for detecting group A streptococcal antigen, which means it aids in diagnosis rather than directly treating a condition.
Yes
The device is described as an "in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens," and its intended use is "as an aid in the clinical diagnosis of group A streptococcal infection."
No
The device is an in vitro diagnostic product that detects group A streptococcal antigen from throat swab specimens, indicating it involves physical components for sample collection and analysis, not just software.
Yes, based on the provided information, the BioStrep® A is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the BioStrep® A is "intended for use as an in vitro diagnostic product".
- Purpose: The purpose is the "qualitative detection of group A streptococcal antigen directly from throat swab specimens," which is a diagnostic test performed outside of the body (in vitro).
- Setting: The intended use in "physician's offices, hospitals, and clinical laboratories" further supports its use in a clinical diagnostic setting.
Therefore, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GTY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's offices, hospitals, and clinical laboratories. Professional Use. Prescription Use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3740
Streptococcus spp. serological reagents.(a)
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 identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
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.
1
Page 2
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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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
2
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:
) -
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)