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The provided document is a 510(k) clearance letter from the FDA for the "Gram-Negative QuickFISH™ BC Blood Culture Identification Kit." This letter grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in the 510(k) submission itself.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, ground truth methods), or the specifics of standalone or MRMC studies from this document.
To answer your questions, I would need access to the actual 510(k) submission for K123418, which would include the clinical and analytical study reports.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002
BENJAMIN S. CRYSTAL DIRECTOR, CLINICAL AND REGULATORY AFFAIRS · ADVANDX, INC. 400 TRADECENTER, SUITE 6990 WOBURN MA 01801-7476
July 21, 2013
Re: K123418
Trade/Device Name: Gram-Negative QuickFISH™ BC Blood Culture Identification Kit Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: I Product Code: JSS Dated: June 18, 2013 Received: June 19, 2013
Dear Mr. Crystal:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Crystal
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sally Aojivat-S
Sally A. Hojvat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
a
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-------------REMOVE THIS PAGE WHEN PRINTING OR EMAILING TO SPONSOR----------
510(k) Number: K123418
| Digital Signature Concurrence Table | |
|---|---|
| Reviewer Sign-Off | Michael S. Waters -S2013.07.18 07:56:04 -04'00' |
| Branch Chief Sign-Off | John Hobson -S2013.07.18 08:24:08 -04'00' |
| Division Sign-Off | Sally A. Hojvat -S2013.07.21 15:47:10 -04'00' |
Template Name: OIR Letter Generator v1.05 - Letter type: SE
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of 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.