(139 days)
The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.
Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Staphylococcus QuickFISH BC." This document primarily focuses on the regulatory clearance for the device and its intended use, rather than a detailed study report with specific acceptance criteria and performance data.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The FDA letter is a clearance notification and does not detail the specific performance metrics or acceptance criteria used in the underlying studies that led to the clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The letter does not describe the specific studies or their methodologies.
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):
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This information is not provided and is likely not applicable. The device, "Staphylococcus QuickFISH BC," is described as a "qualitative nucleic acid hybridization assay" for identifying bacteria directly from blood cultures. This is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the document doesn't explicitly state "standalone performance study," the nature of an in-vitro diagnostic test like the QuickFISH BC implies that its performance is evaluated in a standalone manner, separate from human interpretation of complex images or data that AI might assist with. The test itself provides a qualitative result. However, the details of such evaluation are not provided here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document. For an in-vitro diagnostic test, ground truth would typically be established by established microbiological culture methods and advanced molecular techniques for bacterial identification.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter, which confirms that the Staphylococcus QuickFISH BC device is deemed substantially equivalent to existing devices and can be marketed. It defines the "Indications for Use" for the device, which involves the identification of Staphylococcus aureus and/or coagulase-negative staphylococci from positive blood cultures with gram-positive cocci in clusters. It also notes that sub-culturing is still necessary for susceptibility testing.
However, the letter does not contain the detailed study data, acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications that would typically be found in a study report or a more extensive FDA review summary. These details would have been part of the 510(k) submission made by AdvanDx, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by a serpent, and it is positioned to the right of the text.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
APR - 3 2012
AdvanDx. Inc. c/o Mr. Benjamin S. Crystal Clinical and Regulatory Affairs Manager 400 TradeCenter, Suite 6990 Woburn, MA 01801
Re: K113371
Trade/Device Name: Staphylococcus QuickFISH™ BC Regulation Number: 21 CFR 866.3700 Regulation Name : FISH (Fluorescent in situ hybridization) kit, Protein Nuclei Acid, RNA, Staphylococcus aureus
Regulatory Class: Class I Product Code: NXX Dated: March 27, 2012 Received: March 29, 2012
Dear Mr. Crystal:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave toviewed your becalling 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 Connineres prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have been receasined in access approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and COSMECE Act (1 tell that do not request to the general controls provisions of the Act. The You may, merciole, market the device, books of the universe for annual registration, listing of general Controls provisions of the recess labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 21 If your device is Classifica (see above) into exas ffecting your device can be found in Title 21, additional controls. Existing major regarations and to 895. In addition, FDA may publish further Cour of Pouchar concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated or a baoines with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a determination that your steers a goncered by other Federal agencies. You must or any Federal statutes and regulations annumbles, but not limited to: registration and listing (21
comply with all the Act's requirements, including, and seess reporting (re comply with an the Act s requirements, morating, on medical device reporting (reporting of
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Page 2 - Benjamin S. Crystal
medical device-related adverse events) (21 CFR 803); and good manufacturing pactice modical device readed adverse creatity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in keting your device as described in your Section 510(k) premarket will anow you to begal mation of substantial equivalence of your device to a legally marketed nonication. The I Driving of seation 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 Parts 801 and If you desire specific ad rice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (21 OF N Party/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may other other general meethances one Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Salgattyns
Sally A. Hojvat, M.Šc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): 113371
Device Name: Staphylococcus QuickFISH BC
Indications for Use:
The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.
Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luedde h. Paole
Avision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113371
§ 866.3700
Staphylococcus aureus serological reagents.(a)
Identification. Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genusStaphylococcus and provides epidemiological information on these diseases. Certain strains ofStaphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).(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 the limitations in § 866.9.