(195 days)
GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gramnegative rods observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli, and/or K, pneumoniae, and/or P. aeruginosa bacteremia.
Not Found
This document is a 510(k) clearance letter for the AdvanDX GNR Traffic Light PNA FISH Identification Kit. It does not contain the detailed study information required to answer your request.
The letter acknowledges the substantial equivalence determination for the device based on a premarket notification. It outlines the regulatory classification, general controls, and responsibilities of the manufacturer. However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details on multi-reader multi-case (MRMC) studies or standalone performance.
- The type of ground truth used, or sample sizes and ground truth establishment methods for a training set.
To obtain this information, you would typically need to refer to the original 510(k) submission document (K101558) itself, which would contain the validation study details.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
DEC 1 6 2010
AdvanDx, Inc. c/o Benjamin S. Crystal Clinical and Regulatory Affairs Manager 400 Trade Center Suite 6990 Woburn, MA 01801
| Re: | K101558/S1 |
|---|---|
| Trade/Device Name: | AdvanDX GNR Traffic Light PNA FISH Identification Kit |
| Regulation Number: | 21CFR §862.2660 |
| Regulation Name: | Microorganism differentiation and identification device. |
| Regulatory Class: | Class I |
| Product Code: | JSS |
| Dated: | December 10, 2010 |
| Received: | December 13, 2010 |
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.
If your device is classified (see above) into class II (Special Controls), 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 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. This letter will allow you to begin marketing your device as described in your Section
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Page 2 - Benjamin S. Crystal
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 809), please contact the Office 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
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/cdrh/industry/support/index.html.
Sincerely vours.
Sallatton
Sally A. Hojvat, M.Sc., 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): K101558
Device Name: GNR Traffic Light PNA FISH®
Indications for Use:
. .
.
GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gramnegative rods observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli, and/or K, pneumoniae, and/or P. aeruginosa bacteremia.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Lualdie lu. Poole
Division Sign-Off
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Office of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
Constitution and Safety Office of in 10 Safety
Evaluation and Safety
510(k) K101558
§ 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.