(16 days)
SASTM StrepAlert is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.
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This document is a 510(k) clearance letter from the FDA for the SAS™ StrepAlert device, which is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens.
Generally, 510(k) clearances establish substantial equivalence to a predicate device rather than showing proof of meeting specific acceptance criteria through a detailed study. Such studies are typically part of a PMA (Premarket Approval) application for higher-risk devices.
Based on the provided document, the following information can be extracted regarding the "study" referenced implicitly by the 510(k) clearance, which would be a comparison to a predicate device:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of performance data. For a 510(k), the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device. This usually involves showing comparable performance (e.g., sensitivity, specificity) but detailed numerical criteria and results are not present in this summary letter. -
Sample size used for the test set and the data provenance
This information is not provided in the FDA clearance letter. Such details would typically be found in the 510(k) submission itself, not in the summary letter. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the FDA clearance letter. For a test detecting a biological antigen, the "ground truth" would likely be established through bacterial culture. -
Adjudication method for the test set
This information is not provided in the FDA clearance letter. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This is highly unlikely for a rapid in vitro diagnostic test like StrepAlert. MRMC studies are typically for imaging devices where human readers interpret results "with and without AI assistance." The SAS™ StrepAlert is a "rapid visual test" for antigen detection, not an image interpretation system. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as a "rapid visual test," implying human interpretation of results (e.g., color change on a test strip). Therefore, a "standalone algorithm only" performance would not be applicable in the sense of a machine learning algorithm. Its performance is inherent to the chemical reactions and visual indicators. -
The type of ground truth used
While not explicitly stated in this document, for in vitro diagnostic tests for bacterial antigens, the gold standard "ground truth" is almost universally bacterial culture. That is, a throat swab would be cultured to definitively identify the presence or absence of Group A Streptococcus, and this result would be compared to the rapid test result. -
The sample size for the training set
This information is not provided. For this type of rapid diagnostic test, there isn't a "training set" in the machine learning sense. The device's performance is based on its chemical and biological design, which is validated through clinical studies rather than by training a model on data. -
How the ground truth for the training set was established
As there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The device's performance characteristics are inherent to its design and validated against a biological gold standard (likely culture) in clinical trials.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 7 2002
Mr. Ricardo R. Martinez Director, Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240
Re: K023270
Trade/Device Name: SAS™ StrepAlert Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. Serological reagents Regulatory Class: Class I Product Code: GTY Dated: September 30, 2002 Received: October 1, 2002
Dear Mr. Martinez:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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INDICATIONS FOR USE
Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: (210) 699-8800 Fax: (210) 6996545
Establishment Reg. No.: 1645225
501(k) Number: K023 270
Device Name:
SASTM StrepAlert
Indications for Use:
SASTM StrepAlert is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens.
The test is for professional use.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Freddie Poole
(Division Sian-Off Division of Clinica 510(k) Number
Prescription Use Use U
Or
Over-the-Counter
§ 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.