(88 days)
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No
The summary describes a qualitative immunoassay for detecting a specific antigen, which is a biochemical test and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
The device is described as an "Immunoassay for the qualitative detection of Group A Streptococcal antigen," which is a diagnostic purpose, not a therapeutic one. It aids in early diagnosis but does not treat or cure.
Yes
The intended use explicitly states "to aid in the early diagnosis of Group A Streptococcal infection," which is the definition of a diagnostic device.
No
The device is an immunoassay, which is a laboratory test that uses antibodies to detect and measure specific substances. This inherently involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "Immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens." This involves testing a sample taken from the human body (throat swab) in vitro (outside the body) to provide diagnostic information.
- Specimen Type: It uses "throat swab specimens," which are biological samples taken from a patient.
- Purpose: The purpose is to "aid in the early diagnosis of Group A Streptococcal infection," which is a diagnostic purpose.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
Product codes
GTY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
throat swab specimens
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jemo Kang, Ph.D. Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543
Dated: June 16, 1997 Received: June 18, 1997
JUL - 7 1997
Re: K971349 Trade Name: BioSign Strep A - Direct Strep A Antigen Test Regulatory Class: I Product Code: GTY
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 (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 vour 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
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510(k) Number (if known): K971349
BioSign™ Strep A Device Name:
Immunoassay for the qualitative detection of Group Indications For Usc: Immanoussay 201 ontigen directly from throat swab specimens to aid in the early diagnosis of Group A . Streptococcal infection. . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alan Rubin
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971349
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use
(Optional Formal 1-2-96)