(421 days)
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.
Not Found
The provided document is a 510(k) clearance letter for the BioStar STREP A OIA® MAX assay, not a study report. As such, it does not contain the detailed information necessary to answer all the questions about acceptance criteria and a study proving the device meets them.
However, based on the context of a 510(k) clearance, we can infer some general aspects and extract limited information.
Here's what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully answered from this document. This document is a clearance letter, not a clinical study report. It does not provide specific acceptance criteria values (e.g., minimum sensitivity, specificity) or the reported device performance against those criteria. Such details would typically be found in the 510(k) submission summary or a separate clinical study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from this document. The document does not specify the sample size of any test set or the provenance of the data used for validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Cannot be answered from this document. For an in vitro diagnostic device like this, the "ground truth" would typically be established by a reference method (e.g., bacterial culture) rather than expert consensus on images. The document does not provide details on how ground truth was established, nor does it refer to "experts" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be answered from this document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data. For an in vitro diagnostic assay, the "ground truth" is usually determined by objective laboratory methods, not by human adjudication of independent expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not applicable to an in vitro diagnostic device. MRMC studies are relevant for AI-powered image analysis devices where human readers interpret medical images. The BioStar STREP A OIA® MAX is a rapid in vitro diagnostic assay for antigen detection, not an AI-based imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone in vitro diagnostic assay. Its performance is evaluated on its own ability to detect the Group A Streptococcal antigen. There isn't a "human-in-the-loop" aspect to its fundamental operation or interpretation. Its performance would be assessed as a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred: For a diagnostic assay like Strep A OIA, the ground truth would almost certainly be established by a bacterial culture of the throat swab specimen. Culture is the gold standard for detecting the presence of Group A Streptococcus.
8. The sample size for the training set
- Not applicable/Cannot be answered from this document. This is an antigen detection assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its development would involve optimization and validation, but not typically a labeled training data set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As mentioned above, there isn't a "training set" in the AI/ML context for this type of device.
Summary based on available information:
The provided document is limited to a 510(k) clearance letter for the BioStar® STREP A OIA® MAX assay. It indicates the device is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs as an aid in diagnosing streptococcal pharyngitis.
While the letter confirms the device was found substantially equivalent to a predicate device, it does not contain the detailed performance data or study methodology typically found in a clinical study report or the 510(k) summary (which is a separate document). Therefore, most of the specific questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be definitively answered from this document alone. We can infer that its performance as a standalone in-vitro diagnostic was evaluated, with bacterial culture likely serving as the ground truth.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized symbol that resembles three human profiles merging into a single form, often interpreted as representing the department's mission to protect and promote the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 3 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 CMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 Requlations.
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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 asboing 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Page 1 of 1
510(k) Number (if known): __K962060
Strep A OIA® MAX Device Name:
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) |
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Division of Clinical Laboratory Devices
| 510(k) Number | K962060 |
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| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
§ 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.